
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Notices]
[Pages 19196-19205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07467]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 041

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a publication containing modifications the Agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
Recognized Consensus Standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 041'' (Recognition List Number: 041), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit electronic or written comments concerning this document 
at any time. These modifications to the list of recognized standards 
are effective April 4, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your

[[Page 19197]]

comment does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of 
1997: Modifications to the List of Recognized Standards, Recognition 
List Number: 041.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will 
consider any comments received in determining whether to amend the 
current listing of modifications to the list of recognized standards, 
Recognition List Number: 041.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of Recognition List Number: 041 is available on 
the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of 
this document for electronic access to the searchable database for the 
current list of FDA recognized consensus standards, including 
Recognition List Number: 041 modifications and other standards related 
information. Submit written requests for a single hard copy of the 
document entitled ``Modifications to the List of Recognized Standards, 
Recognition List Number: 041'' to the Division of Industry and Consumer 
Education, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request, or fax your request to 301-847-
8149.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6287, standards@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standards recognition program and provided 
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains hypertext 
markup language (HTML) and portable document format (PDF) versions of 
the list of FDA Recognized Consensus Standards. Both versions are 
publicly accessible at the Agency's Internet site. See section VI of 
this document for electronic access information. Interested persons 
should review the supplementary information sheet for the standard to 
understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 041

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in premarket submissions and other requirements for devices. FDA 
will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. FDA will use 
the term ``Recognition List Number: 041'' to identify these current 
modifications.
    In table 1, FDA describes the following modifications: (1) The 
withdrawal of standards and their replacement by others, if applicable; 
(2) the correction of errors made by FDA in listing previously 
recognized standards; and (3) the changes to the supplementary 
information sheets of recognized standards that describe

[[Page 19198]]

revisions to the applicability of the standards.
    In section III, FDA lists modifications the Agency is making that 
involve the initial addition of standards not previously recognized by 
FDA.

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                                     Replacement
       Old recognition No.           recognition         Title of standard \1\                  Change
                                         No.
----------------------------------------------------------------------------------------------------------------
                                                  A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-92.............................           1-106  ISO 17510 First Edition 2015-08-  Withdrawn and replaced with
                                                    01 Medical Devices--Sleep         newer version.
                                                    Apnoea Breathing Therapy--Masks
                                                    and Application Accessories.
1-93.............................  ..............  ISO 5361 Second Edition 2012-10-  Extent of recognition.
                                                    01 Anaesthetic and Respiratory
                                                    Equipment--Tracheal Tubes and
                                                    Connectors.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-180............................  ..............  ANSI/AAMI/ISO 10993-16:2010/(R)   Reaffirmation.
                                                    2014 Biological evaluation of
                                                    medical devices--Part 16:
                                                    Toxicokinetic study design for
                                                    degradation products and
                                                    leachables.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-119............................  ..............  ISO 5841-3 Third Edition 2013-04- Withdrawn--Duplicate
                                                    15 Implants for surgery--         recognition--See 3-125.
                                                    Cardiac pacemakers--Part 3: Low-
                                                    profile connectors [is-i] for
                                                    implantable pacemakers.
3-138............................  ..............  ASTM F2942-13 Standard Guide For  Extent of recognition.
                                                    the In Vitro Axial, Bending,
                                                    and Rotational Durability Test
                                                    of Vascular Stents.
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-121............................           4-221  ISO 7494-2 Second Edition 2015-   Withdrawn and replaced with
                                                    04-01 Dentistry--Dental units--   newer version.
                                                    Part 2: Air, water, suction and
                                                    wastewater system.
4-132............................           4-222  ISO 6874 Third Edition 2015-09-   Withdrawn and replaced with
                                                    01 Dentistry--Polymer-based pit   newer version.
                                                    and fissure sealants.
4-178............................           4-223  ISO 6872 Fourth Edition 2015-06-  Withdrawn and replaced with
                                                    01 Dentistry--Ceramic materials.  newer version.
4-190............................  ..............  ANSI/ASA S3.35-2010 (R2015)       Reaffirmation.
                                                    Method of Measurement of
                                                    Performance Characteristics of
                                                    Hearing Aids Under Simulated
                                                    Real-Ear Working Conditions.
4-194............................  ..............  ANSI/ADA Specification No. 78:    Extent of recognition.
                                                    2006, Dental Obturating Cones
                                                    (Modified adoption of ISO 6877-
                                                    1:1995, Dental Obturating
                                                    Points).
4-202............................  ..............  ANSI/ADA Specification No. 58     Extent of recognition.
                                                    Root Canal Files, Type H
                                                    (Hedstrom).
4-209............................           4-224  ISO 24234 Second Edition 2015-05- Withdrawn and replaced with
                                                    01 Dentistry--Dental amalgam.     newer version.
4-210............................           4-225  ISO 4823 Fourth Edition 2015-08-  Withdrawn and replaced with
                                                    01 Dentistry--Elastomeric         newer version.
                                                    impression materials.
4-213............................  ..............  ISO 7494-1 Second Edition 2011-   Extent of recognition.
                                                    08-15 Dentistry--Dental units--
                                                    Part 1: General requirements
                                                    and test methods.
4-214............................  ..............  ISO 10139-1 Second Edition 2005-  Extent of recognition.
                                                    02-15 Dentistry--Soft lining
                                                    materials for removable
                                                    dentures--Part 1: Materials for
                                                    short-term use [Including:
                                                    Technical Corrigendum 1 (2006)].
----------------------------------------------------------------------------------------------------------------
                              E. General I (Quality Systems/Risk Management (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-43.............................            5-98  ANSI/ESD S20.20-2014 Protection   Withdrawn and replaced with
                                                    of Electrical and Electronic      newer version.
                                                    Parts, Assemblies, and
                                                    Equipment (Excluding
                                                    Electrically Initiated
                                                    Explosive Devices).
5-80.............................            5-99  ASTM D4332-14 Standard Practice   Withdrawn and replaced with
                                                    for Conditioning Containers,      newer version.
                                                    Packages, or Packaging
                                                    Components for Testing.
----------------------------------------------------------------------------------------------------------------
                     F. General II (Electrical Safety/Electromagnetic Compatibility)(ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-7.............................           19-16  ANSI/AAMI HA60601-1-11:2015 (IEC  Withdrawn and replaced with
                                                    60601-1-11:2015, MOD) MEDICAL     newer version.
                                                    ELECTRICAL EQUIPMENT--Part 1-
                                                    11: General requirements for
                                                    basic safety and essential
                                                    performance--Collateral
                                                    Standard: Requirements for
                                                    medical electrical equipment
                                                    and medical electrical systems
                                                    used in the home healthcare
                                                    environment.
19-7.............................  ..............  AAMI/ANSI HA60601-1-11:2011,      Transition period.
                                                    Medical electrical equipment--
                                                    Part 1-11: General requirements
                                                    for basic safety and essential
                                                    performance--Collateral
                                                    standard: Requirements for
                                                    medical electrical equipment
                                                    and medical electrical
                                                    equipment and medical
                                                    electrical systems used in the
                                                    home healthcare environment
                                                    (IEC 60601-1-11:2010 MOD).
----------------------------------------------------------------------------------------------------------------

[[Page 19199]]

 
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-169............................           6-355  ASTM D3772--15 Standard           Withdrawn and replaced with
                                                    Specification for Industrial      newer version.
                                                    Rubber Finger Cots.
6-243............................           6-356  ASTM D5712--15 Standard Test      Withdrawn and replaced with
                                                    Method for Analysis of Aqueous    newer version.
                                                    Extractable Protein in Latex,
                                                    Natural Rubber, and Elastomeric
                                                    Products Using the Modified
                                                    Lowry Method.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-167............................           7-259  CLSI GP23-A Nongynecologic        Withdrawn and replaced with
                                                    Cytologic Specimens: Collection   newer version.
                                                    And Cytopreparatory Techniques;
                                                    Approved Guideline.
7-132............................           7-260  CLSI MM03-A2 Molecular            Withdrawn and replaced with
                                                    Diagnostic Methods for            newer version.
                                                    Infectious Diseases; Approved
                                                    Guideline.
7-229............................  ..............  CLSI M02-A11 Performance          Withdrawn. See 7-258.
                                                    Standards for Antimicrobial
                                                    Disk Susceptibility Tests;
                                                    Approved Standard--Eleventh
                                                    Edition.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-103............................  ..............  ASTM F1807-97 (Reapproved 2014)   Reaffirmation.
                                                    Standard Practice for Corrosion
                                                    Fatigue Testing of Metallic
                                                    Implant Materials.
8-107............................  ..............  ASTM F746-04 (Reapproved 2014)    Reaffirmation.
                                                    Standard Test Method for
                                                    Pitting or Crevice Corrosion of
                                                    Metallic Surgical Implant
                                                    Materials.
8-114............................  ..............  ASTM F2255-05 (Reapproved 2015)   Reaffirmation.
                                                    Standard Test Method for
                                                    Strength Properties of Tissue
                                                    Adhesives in Lap-Shear by
                                                    Tension Loading.
8-115............................  ..............  ASTM F2256-05 (Reapproved 2015)   Reaffirmation.
                                                    Standard Test Method for
                                                    Strength Properties of Tissue
                                                    Adhesives in T-Peel by Tension
                                                    Loading.
8-116............................  ..............  ASTM F2258-05 (Reapproved 2015)   Reaffirmation.
                                                    Standard Test Method for
                                                    Strength Properties of Tissue
                                                    Adhesives in Tension.
8-121............................  ..............  ASTM F2005-05 (Reapproved 2015)   Reaffirmation.
                                                    Standard Terminology for Nickel-
                                                    Titanium Shape Memory Alloys.
8-134............................           8-392  ASTM F2082-15 Standard Test       Withdrawn and replaced with
                                                    Method for Determination of       newer version.
                                                    Transformation Temperature of
                                                    Nickel-Titanium Shape Memory
                                                    Alloys by Bend and Free
                                                    Recovery.
8-135............................  ..............  ASTM F2392-04 (Reapproved 2015)   Reaffirmation.
                                                    Standard Test Method for Burst
                                                    Strength of Surgical Sealants.
8-136............................  ..............  ASTM F2458-05 (Reapproved 2015)   Reaffirmation.
                                                    Standard Test Method for Wound
                                                    Closure Strength of Tissue
                                                    Adhesives and Sealants.
8-167............................           8-393  ASTM F1350-15 Standard            Withdrawn and replaced with
                                                    Specification for Wrought         newer version.
                                                    18Chromium-14Nickel-
                                                    2.5Molybdenum Stainless Steel
                                                    Surgical Fixation Wire (UNS
                                                    S31673).
8-168............................           8-394  ASTM F1472-14 Standard            Withdrawn and replaced with
                                                    Specification for Wrought         newer version.
                                                    Titanium-6Aluminum-4Vanadium
                                                    Alloy for Surgical Implant
                                                    Applications (UNS R56400).
8-170............................           8-395  ASTM F961-14 Standard             Withdrawn and replaced with
                                                    Specification for 35Cobalt-       newer version.
                                                    35Nickel-20Chromium-
                                                    10Molybdenum Alloy Forgings for
                                                    Surgical Implants (UNS R30035).
8-177............................           8-396  ASTM F2129-15 Standard Test       Withdrawn and replaced with
                                                    Method for Conducting Cyclic      newer version.
                                                    Potentiodynamic Polarization
                                                    Measurements to Determine the
                                                    Corrosion Susceptibility of
                                                    Small Implant Devices.
8-179............................  ..............  ASTM F754-08 (Reapproved 2015)    Reaffirmation.
                                                    Standard Specification for
                                                    Implantable
                                                    Polytetrafluoroethylene (PTFE)
                                                    Sheet, Tube, and Rod Shapes
                                                    Fabricated from Granular
                                                    Molding Powders.
8-184............................           8-397  ASTM F2516-14 Standard Test       Withdrawn and replaced with
                                                    Method for Tension Testing of     newer version.
                                                    Nickel-Titanium Superelastic
                                                    Materials.
8-189............................           8-398  ASTM F1108-14 Standard            Withdrawn and replaced with
                                                    Specification for Titanium-       newer version.
                                                    6Aluminum-4Vanadium Alloy
                                                    Castings for Surgical Implants
                                                    (UNS R56406).
8-190............................           8-399  ASTM F90-14 Standard              Withdrawn and replaced with
                                                    Specification for Wrought         newer version.
                                                    Cobalt-20Chromium-15Tungsten-
                                                    10Nickel Alloy for Surgical
                                                    Implant Applications (UNS
                                                    R30605).
8-192............................           8-400  ASTM F1854-15 Standard Test       Withdrawn and replaced with
                                                    Method for Stereological          newer version.
                                                    Evaluation of Porous Coatings
                                                    on Medical Implants.
8-200............................  ..............  ASTM F2003-02 (Reapproved 2015)   Reaffirmation.
                                                    Standard Practice for
                                                    Accelerated Aging of Ultra-High
                                                    Molecular Weight Polyethylene
                                                    after Gamma Irradiation in Air.
8-204............................           8-401  ASTM F2118-14 Standard Test       Withdrawn and replaced with
                                                    Method for Constant Amplitude     newer version.
                                                    of Force Controlled Fatigue
                                                    Testing of Acrylic Bone Cement
                                                    Materials.

[[Page 19200]]

 
8-206............................           8-402  ASTM F688-14 Standard             Withdrawn and replaced with
                                                    Specification for Wrought         newer version.
                                                    Cobalt-35Nickel-20Chromium
                                                    10Molybdenum Alloy Plate,
                                                    Sheet, and Foil for Surgical
                                                    Implants (UNS R30035).
8-225............................  ..............  ASTM F2003-02 (Reapproved 2015)   Withdrawn. See 8-200.
                                                    Standard Practice for
                                                    Accelerated Aging of Ultra-High
                                                    Molecular Weight Polyethylene
                                                    after Gamma Irradiation in Air.
8-363............................           8-403  ASTM D638-14 Standard Test        Withdrawn and replaced with
                                                    Method for Tensile Properties     newer version.
                                                    of Plastics.
8-367............................           8-404  ASTM E647-15 Standard Test        Withdrawn and replaced with
                                                    Method for Measurement of         newer version.
                                                    Fatigue Crack Growth Rates.
8-369............................  ..............  ASTM F2003-02 (Reapproved 2015)   Withdrawn. See 8-200.
                                                    Standard Practice for
                                                    Accelerated Aging of Ultra-High
                                                    Molecular Weight Polyethylene
                                                    after Gamma Irradiation in Air.
8-386............................           8-405  ISO 5832-4 Third Edition 2014-09- Withdrawn and replaced with
                                                    15 Implants for surgery--         newer version.
                                                    Metallic materials--Part 4:
                                                    Cobalt-chromium-molybdenum
                                                    casting alloy.
8-387............................           8-406  ISO 5832-11 Second Edition 2014-  Withdrawn and replaced with
                                                    09-15 Implants for surgery--      newer version.
                                                    Metallic materials--Part 11:
                                                    Wrought titanium 6-aluminium 7-
                                                    niobium alloy.
----------------------------------------------------------------------------------------------------------------
                                                J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-1.............................  ..............  ASTM E2490-09 (Reapproved 2015)   Reaffirmation.
                                                    Standard Guide for Measurement
                                                    of Particle Size Distribution
                                                    of Nanomaterials in Suspension
                                                    by Photon Correlation
                                                    Spectroscopy (PCS).
----------------------------------------------------------------------------------------------------------------
                               K. Obstetrics-Gynecology (OB-GYN)/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-61.............................  ..............  IEC 60601-2-18 Edition 3.0 2009-  Withdrawn. Merged with 4-
                                                    08 Medical Electrical             187.
                                                    Equipment--Part 2-18:
                                                    Particular requirements for the
                                                    basic safety and essential
                                                    performance of endoscopic
                                                    equipment.
9-83.............................           9-110  ISO 8600-1 Fourth Edition 2015-   Withdrawn and replaced with
                                                    10-15 Endoscopes--Medical         newer version.
                                                    endoscopes and endotherapy
                                                    devices--Part 1: General
                                                    requirements.
9-96.............................  ..............  CEN EN 1618:1997 Catheters Other  Duplicate recognition
                                                    Than Intravascular Catheters--    number. See 9-113.
                                                    Test Methods for Common
                                                    Properties.
9-102............................           9-111  ISO 4074 Third Edition 2015-10-   Withdrawn and replaced with
                                                    15 Natural rubber latex male      newer version.
                                                    condoms--Requirements and test
                                                    methods.
9-109............................           9-112  ASTM D3492-15 Standard            Withdrawn and replaced with
                                                    Specification for Rubber          newer version.
                                                    Contraceptives (Male Condoms).
----------------------------------------------------------------------------------------------------------------
                                                  L. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-73............................  ..............  ANSI Z80.21-2010 (R2015)          Reaffirmation.
                                                    Ophthalmics--Instruments--Gener
                                                    al-Purpose Clinical Visual
                                                    Acuity Charts.
----------------------------------------------------------------------------------------------------------------
                                                  M. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-207...........................          11-296  ASTM F2193-14 Standard            Withdrawn and replaced with
                                                    Specifications and Test Methods   newer version.
                                                    for Components Used in the
                                                    Surgical Fixation of the Spinal
                                                    Skeletal System.
11-214...........................          11-297  ASTM F382--14 Standard            Withdrawn and replaced with
                                                    Specification and Test Method     newer version.
                                                    for Metallic Bone Plates.
11-216...........................          11-298  ASTM F1264--14 Standard           Withdrawn and replaced with
                                                    Specification and Test Methods    newer version.
                                                    for Intramedullary Fixation
                                                    Devices.
11-220...........................          11-299  ASTM F2068--15 Standard           Withdrawn and replaced with
                                                    Specification for Femoral         newer version.
                                                    Prostheses--Metallic Implants.
11-227...........................  ..............  ASTM F366-10 (Reapproved 2015)    Reaffirmation.
                                                    Standard Specification for
                                                    Fixation Pins and Wires.
11-228...........................  ..............  ASTM F564-10 (Reapproved 2015)    Reaffirmation.
                                                    Standard Specification and Test
                                                    Methods for Metallic Bone
                                                    Staples.
11-247...........................  ..............  ASTM F2789-10 (Reapproved 2015)   Reaffirmation.
                                                    Standard Guide for Mechanical
                                                    and Functional Characterization
                                                    of Nucleus Devices.
11-256...........................  ..............  ISO 14243-3 First Edition 2004-   Withdrawn. See 11-292.
                                                    09-25 Implants for surgery--
                                                    Wear of total knee-joint
                                                    prostheses--Part 3: Loading and
                                                    displacement parameters for
                                                    wear-testing machines with
                                                    displacement control and
                                                    corresponding environmental
                                                    conditions for test [Including:
                                                    Technical Corrigendum 1(2006)].
11-262...........................          11-301  ASTM F2091-15 Standard            Withdrawn and replaced with
                                                    Specification for Acetabular      newer version.
                                                    Prostheses.

[[Page 19201]]

 
11-278...........................          11-302  ASTM F1717-15 Standard Test       Withdrawn and replaced with
                                                    Methods for Spinal Implant        newer version.
                                                    Constructs in a Vertebrectomy
                                                    Model.
----------------------------------------------------------------------------------------------------------------
                                              N. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-158...........................          16-195  ISO 7176-1 Third Edition 2014-10- Withdrawn and replaced with
                                                    01 Wheelchairs--Part 1:           newer version.
                                                    Determination of static
                                                    stability.
----------------------------------------------------------------------------------------------------------------
                                                  O. Radiology
----------------------------------------------------------------------------------------------------------------
12-139...........................  ..............  NEMA UD 2-2004 (R2009) Acoustic   Reaffirmation.
                                                    output measurement standard for
                                                    diagnostic ultrasound
                                                    equipment, Revision 3.
12-187...........................  ..............  NEMA MS 3-2008 (R2014)            Reaffirmation.
                                                    Determination of Image
                                                    Uniformity in Diagnostic
                                                    Magnetic Resonance Images.
12-188...........................  ..............  NEMA MS 1-2008 (R2014)            Reaffirmation.
                                                    Determination of Signal-to-
                                                    Noise Ratio (SNR) in Diagnostic
                                                    Magnetic Resonance Imaging.
12-195...........................  ..............  NEMA MS 6-2008 (R2014)            Reaffirmation.
                                                    Determination of Signal-to-
                                                    Noise Ratio and Image
                                                    Uniformity for Single-Channel,
                                                    Non-Volume Coils in Diagnostic
                                                    Magnetic Resonance Imaging
                                                    (MRI).
12-196...........................  ..............  NEMA MS 2-2008 (R2014)            Reaffirmation.
                                                    Determination of Two-
                                                    Dimensional Geometric
                                                    Distortion in Diagnostic
                                                    Magnetic Resonance Images.
12-207...........................  ..............  IEC 60601-2-33 Ed. 3.0 2010       Extent of recognition.
                                                    Medical electrical equipment--
                                                    Part 2-33: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of magnetic
                                                    resonance equipment for medical
                                                    diagnosis.
12-209...........................          12-293  IEC 60601-2-37 Ed. 2.1 b:2015     Withdrawn and replaced with
                                                    Medical electrical equipment--    newer version.
                                                    Part 2-37: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of ultrasonic
                                                    medical diagnostic and
                                                    monitoring equipment.
12-236...........................          12-294  IEC 60601-2-45 Ed. 3.1 b:2015     Withdrawn and replaced with
                                                    Medical electrical equipment--    newer version.
                                                    Part 2-45: Particular
                                                    requirements for basic safety
                                                    and essential performance of
                                                    mammographic X-ray equipment
                                                    and mammographic stereotactic
                                                    devices.
12-257...........................          12-297  ISO 2919 Third Edition 2012-02-   Duplicate recognition
                                                    15 Radiation protection--Sealed   number. See 12-297.
                                                    radioactive sources--General
                                                    requirements and classification.
12-271...........................          12-295  IEC 60601-2-33 Ed. 3.2 b:2015     Withdrawn and replaced with
                                                    Medical electrical equipment--    newer version.
                                                    Part 2-33: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of magnetic
                                                    resonance equipment for medical
                                                    diagnosis.
12-274...........................          12-296  IEC 60601-2-54 Ed. 1.1 b:2015     Withdrawn and replaced with
                                                    Medical electrical equipment--    newer version.
                                                    Part 2-54: Particular
                                                    requirements for the basic
                                                    safety and essential
                                                    performance of X-ray equipment
                                                    for radiography and radioscopy.
12-288...........................  ..............  NEMA MS 9-2008 (R2014)            Reaffirmation.
                                                    Characterization of Phased
                                                    Array Coils for Diagnostic
                                                    Magnetic Resonance Images (MRI).
----------------------------------------------------------------------------------------------------------------
                                             P. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-8.............................           13-79  IEC 62304 Edition 1.1 2015-06     Withdrawn and replaced with
                                                    Medical device software--         newer version.
                                                    Software life cycle processes.
13-50............................           13-80  IEEE Std. 11073-20601: 2014       Withdrawn and replaced with
                                                    Health informatics--Personal      newer version.
                                                    health device communication--
                                                    Part 20601: Application
                                                    profile--Optimized Exchange
                                                    Protocol [including:
                                                    Corrigendum 1 (2015)].
13-51............................  ..............  IEEE Std. 11073-20601a-2010       Withdrawn. See 13-80.
                                                    Health informatics--Personal
                                                    health device communication--
                                                    Part 20601: Application
                                                    profile--Optimized Exchange
                                                    Protocol Amendment 1.
----------------------------------------------------------------------------------------------------------------
                                                  Q. Sterility
----------------------------------------------------------------------------------------------------------------
14-227...........................  ..............  ANSI/AAMI/ISO 11737-1:2006        Extent of recognition.
                                                    (R)2011 Sterilization of health
                                                    care products--Microbiological
                                                    methods--Part 1: Determination
                                                    of the population of
                                                    microorganisms on product.
14-261...........................  ..............  ANSI/AAMI/ISO 17665-1:2006/       Extent of recognition.
                                                    (R)2013 Sterilization of health
                                                    care products--Moist heat--Part
                                                    1: Requirements for the
                                                    development, validation, and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-277...........................  ..............  ISO/TS 17665-2 First Edition      Extent of recognition.
                                                    2009-01-15 Sterilization of
                                                    health care products--Moist
                                                    heat--Part 2: Guidance on the
                                                    application of ISO 17665-1.
14-287...........................  ..............  ANSI/AAMI/ISO 11737-2:2009/       Extent of recognition.
                                                    (R)2014 Sterilization of
                                                    medical devices--
                                                    Microbiological methods--Part
                                                    2: Tests of sterility performed
                                                    in the definition, validation,
                                                    and maintenance of a
                                                    sterilization process.

[[Page 19202]]

 
14-291...........................  ..............  ANSI/AAMI/ISO 14937:2009/(R)2013  Extent of recognition.
                                                    Sterilization of healthcare
                                                    products--General requirements
                                                    for characterization of a
                                                    sterilizing agent and the
                                                    development, validation, and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-296...........................  ..............  ANSI/AAMI/ISO 11138-1:2006/       Extent of recognition.
                                                    (R)2010 Sterilization of health
                                                    care products--Biological
                                                    indicators--Part 1: General
                                                    requirements.
14-298...........................  ..............  ANSI/AAMI/ISO 11137-3:2006/       Extent of recognition.
                                                    (R)2010 Sterilization of health
                                                    care products--Radiation--Part
                                                    3: Guidance on dosimetric
                                                    aspects.
14-327...........................  ..............  ISO 11737-2 Second Edition 2009-  Extent of recognition.
                                                    11-15 Sterilization of medical
                                                    devices--Microbiological
                                                    methods--Part 2: Tests of
                                                    sterility performed in the
                                                    definition, validation, and
                                                    maintenance of a sterilization
                                                    process.
14-330...........................  ..............  ISO 11137-3 First Edition 2006-   Extent of recognition.
                                                    04-15 Sterilization of health
                                                    care products--Radiation--Part
                                                    3: Guidance on dosimetric
                                                    aspects.
14-333...........................  ..............  ISO 17665-1 First Edition 2006-   Extent of recognition.
                                                    08-15 Sterilization of health
                                                    care products--Moist heat--Part
                                                    1: Requirements for the
                                                    development, validation, and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-337...........................  ..............  ISO 14937 Second Edition 2009-10- Extent of recognition.
                                                    15 Sterilization of health care
                                                    products--General requirements
                                                    for characterization of a
                                                    sterilizing agent and the
                                                    development, validation, and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-338...........................  ..............  ISO 11138-1 Second Edition 2006-  Extent of recognition.
                                                    07-01 Sterilization of health
                                                    care products--Biological
                                                    indicators--Part 1: General
                                                    requirements.
14-339...........................  ..............  ANSI/AAMI/ISO 20857:2010          Extent of recognition.
                                                    Sterilization of health care
                                                    products--Dry heat--
                                                    Requirements for the
                                                    development, validation, and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-340...........................  ..............  ISO 20857 First Edition 2010-08-  Extent of recognition.
                                                    15 Sterilization of health care
                                                    products--Dry heat--
                                                    Requirements for the
                                                    development, validation, and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-349...........................  ..............  ANSI/AAMI/ISO 13408-3:2006/       Reaffirmation.
                                                    (R)2015 Aseptic processing of
                                                    health care products--Part 3:
                                                    Lyophilization.
14-351...........................  ..............  ANSI/AAMI/ISO 13408-5:2006/       Reaffirmation.
                                                    (R)2015 Aseptic processing of
                                                    health care products--Part 5:
                                                    Sterilization in place.
14-376...........................  ..............  ANSI/AAMI/ISO TIR17665-2:2009     Extent of recognition.
                                                    Sterilization of health care
                                                    products--Moist heat--Part 2:
                                                    Guidance on the application of
                                                    ANSI/AAMI/ISO 17665-1.
14-407...........................  ..............  ISO 11737-1 Second Edition 2006-  Extent of recognition.
                                                    04-01 Sterilization of medical
                                                    devices--Microbiological
                                                    methods--Part 1: Determination
                                                    of a population of
                                                    microorganisms on products
                                                    [Including: Technical
                                                    Corrigendum 1 (2007)].
14-409...........................  ..............  ISO 11137-2 Third Edition 2013-   Extent of recognition.
                                                    06-01 Sterilization of health
                                                    care products--Radiation--Part
                                                    2: Establishing the
                                                    sterilization dose.
14-428...........................  ..............  ISO 11137-1 First Edition 2006-   Extent of recognition.
                                                    04-15 Sterilization of health
                                                    care products--Radiation--Part
                                                    1: Requirements for
                                                    development, validation, and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices [Including:
                                                    Amendment 1 (2013)].
14-438...........................  ..............  ANSI/AAMI/ISO 11137-2:2013        Extent of recognition.
                                                    Sterilization of health care
                                                    products--Radiation--Part 2:
                                                    Establishing the sterilization
                                                    dose.
14-452...........................  ..............  ISO 11135 Second Edition 2014,    Extent of recognition.
                                                    Sterilization of health care
                                                    products--Ethylene oxide--
                                                    Requirements for development,
                                                    validation, and routine control
                                                    of a sterilization process for
                                                    medical devices.
14-461...........................  ..............  ANSI/AAMI/ISO 11137-1:2006/(R)    Extent of recognition.
                                                    2010 Sterilization of health
                                                    care products--Radiation--Part
                                                    1: Requirements for
                                                    development, validation, and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices [Including:
                                                    Amendment 1 (2013)].
----------------------------------------------------------------------------------------------------------------
                                              R. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-8.............................           15-42  ASTM F2064-14 Standard Guide for  Withdrawn and replaced with
                                                    Characterization and Testing of   newer version.
                                                    Alginates as Starting Materials
                                                    Intended for Use in Biomedical
                                                    and Tissue Engineered Medical
                                                    Product Applications.
15-22............................           15-43  ASTM F2791-15 Standard Guide for  Withdrawn and replaced with
                                                    Assessment of Surface Texture     newer version.
                                                    of Non-Porous Biomaterials in
                                                    Two Dimensions.
15-24............................  ..............  ASTM F2721-09 (Reapproved 2014)   Reaffirmation.
                                                    Standard Guide for Pre-clinical
                                                    in vivo Evaluation in Critical
                                                    Size Segmental Bone Defects.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.


[[Page 19203]]

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 041.

                            Table 2--New Entries to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
         Recognition No.                 Title of standard \1\                  Reference No. and date
----------------------------------------------------------------------------------------------------------------
                                                  A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-107............................  Anaesthetic and Respiratory        ANSI/AAMI/ISO 5356-1:2004.
                                    Equipment--Conical Connectors--
                                    Part 1: Cones and Sockets.
1-108............................  Anaesthetic and Respiratory        ANSI/AAMI/ISO 5361:2012.
                                    Equipment--Tracheal Tubes and
                                    Connectors.
1-109............................  Anaesthetic Reservoir Bags.......  ANSI/AAMI/ISO 5362:2006.
1-110............................  Anaesthetic and Respiratory        ANSI/AAMI/ISO 5366-1:2000.
                                    Equipment--Tracheostomy Tubes--
                                    Part 1: Tubes and Connectors for
                                    Use in Adults.
1-111............................  Anaesthetic and Respiratory        ANSI/AAMI/ISO 5366-3:2001.
                                    Equipment--Tracheostomy Tubes--
                                    Part 3: Paediatric Tracheostomy
                                    Tubes.
1-112............................  Lung Ventilators--Part 4:          ANSI/AAMI/ISO 10651-4:2002.
                                    Particular Requirements for
                                    Operator-Powered Resuscitators.
1-113............................  Lung Ventilators for Medical Use-- ANSI/AAMI/ISO 10651-5:2006.
                                    Particular Requirements for
                                    Basic Safety and Essential
                                    Performance--Part 5: Gas-powered
                                    Emergency Resuscitators.
1-114............................  Inhalational Anaesthesia Systems-- ISO 18835 First Edition 2015-04-01.
                                    Draw-over Anaesthetic Systems.
1-115............................  Medical Electrical Equipment--     ISO 80601-2-70 First Edition 2015-01-15.
                                    Part 2-70: Particular
                                    Requirements for Basic Safety
                                    and Essential Performance of
                                    Sleep Apnoea Breathing Therapy
                                    Equipment.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-223............................  Standard Guide for Selecting       ASTM F2901-13.
                                    Tests to Evaluate Potential
                                    Neurotoxicity of Medical Devices.
2-225............................  Standard Practice for Testing for  ASTM F2567-06 (Reapproved 2010).
                                    Classical Complement Activation
                                    in Serum By Solid Materials.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-140............................  Cardiovascular implants--Cardiac   ANSI/AAMI/ISO 5840-3: 2013.
                                    valve prostheses--Part 3: Heart
                                    valve substitutes implanted by
                                    transcatheter techniques.
3-141............................  Implants for surgery--Cardiac      ANSI/AAMI/ISO 5841-3: 2013.
                                    pacemakers--Part 3: Low-profile
                                    connectors (IS-1) for
                                    implantable pacemakers.
----------------------------------------------------------------------------------------------------------------
                                                  D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-226............................  Dentistry--Powered polymerization  ISO 10650 First Edition 2015-09-01.
                                    activators.
----------------------------------------------------------------------------------------------------------------
                                 E. General I (Quality Systems/Risk Management)
----------------------------------------------------------------------------------------------------------------
5-100............................  Small-bore connectors for liquids  ANSI/AAMI/ISO 80369-20:2015.
                                    and gases in healthcare
                                    applications--Part 20: Common
                                    test methods.
5-101............................  Small-bore connectors for liquids  AAMI/CN6:2015.
                                    and gases in healthcare
                                    applications--Part 6: Connectors
                                    for neuraxial applications.
----------------------------------------------------------------------------------------------------------------
                                             F. General II (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-17............................  American National Standard         ANSI/IEEE C63.18-2014.
                                    Recommended Practice for an On-
                                    Site, Ad Hoc Test Method for
                                    Estimating Electromagnetic
                                    Immunity of Medical Devices to
                                    Radiated Radio-Frequency (RF)
                                    Emissions from RF Transmitters.
19-18............................  Safety requirements for            IEC 61010-1 Edition 3.0 2010-06.
                                    electrical equipment for
                                    measurement, control, and
                                    laboratory use--Part 1: General
                                    requirements [Including:
                                    Corrigendum 1 (2011)].
----------------------------------------------------------------------------------------------------------------

[[Page 19204]]

 
                                                    G. GH/GPS
----------------------------------------------------------------------------------------------------------------
6-357............................  Intravascular Catheters--Sterile   ISO 10555-6 First Edition 2015-04-15.
                                    and Single-use Catheters--Part
                                    6: Subcutaneous Implanted Ports.
6-358............................  Infusion Equipment for Medical     ISO 8536-8 Second Edition 2015-06-15.
                                    Use--Part 8: Infusion Sets for
                                    Single Use with Pressure
                                    Infusion Apparatus.
6-359............................  Infusion Equipment for Medical     ISO 8536-9 Second Edition 2015-06-15.
                                    Use--Part 9: Fluid Lines for
                                    Single Use with Pressure
                                    Infusion Equipment.
6-360............................  Infusion Equipment for Medical     ISO 8536-10 Second Edition 2015-06-15.
                                    Use--Part 10: Accessories for
                                    Fluid Lines for Single Use with
                                    Pressure Infusion Equipment.
6-361............................  Infusion Equipment for Medical     ISO 8536-11 Second Edition 2015-06-15.
                                    Use--Part 11: Infusion Filters
                                    for Single Use with Pressure
                                    Infusion Equipment.
----------------------------------------------------------------------------------------------------------------
                                                  H. Materials
----------------------------------------------------------------------------------------------------------------
8-407............................  Standard Specification for         ISO/ASTM 52915 First Edition 2013-06-01.
                                    Additive Manufacturing File
                                    Format (AMF) Version 1.1.
8-408............................  Standard Guide for Evaluating      ASTM F3122-14.
                                    Mechanical Properties of Metal
                                    Materials Made via Additive
                                    Manufacturing Processes.
8-409............................  Standard Specification for         ASTM F2924-14.
                                    Additive Manufacturing Titanium-
                                    6 Aluminum-4 Vanadium with
                                    Powder Bed Fusion.
8-410............................  Standard Guide for Assessment of   ASTM F2902-12.
                                    Absorbable Polymeric Implants.
8-411............................  Specification for Amorphous        ASTM F2579-10.
                                    Poly(lactide) and Poly(lactide-
                                    co-glycolide) Resins for
                                    Surgical Implants.
8-412............................  Standard Practice for Calibration  ASTM F2537-06 (Reapproved 2011).
                                    of Linear Displacement Sensor
                                    Systems Used to Measure
                                    Micromotion.
8-413............................  Standard Test Methods for          ASTM F2819-10 (Reapproved 2015).
                                    Measurement of Straightness of
                                    Bar, Rod, Tubing, and Wire to be
                                    used for Medical Devices.
8-414............................  Standard Practice for Reporting    ASTM F2847-10.
                                    and Assessment of Residues on
                                    Single Use Implants.
8-415............................  Standard Test Method for           ASTM F2778-09 (Reapproved 2015).
                                    Measurement of Percent
                                    Crystallinity of
                                    Polyetheretherketone (PEEK)
                                    Polymers by Means of Specular
                                    Reflectance Fourier Transform
                                    Infrared Spectroscopy (R-FTIR)..
8-416............................  Standard Test Method for Small     ASTM F2977-13.
                                    Punch Testing of Polymeric
                                    Biomaterials Used in Surgical
                                    Implants.
8-417............................  Test Method for Standard Test      ASTM F3044-14.
                                    Method for Evaluating the
                                    Potential for Galvanic Corrosion
                                    for Medical Implants.
8-418............................  Standard Test Methods for          ASTM F640-12.
                                    Determining Radiopacity for
                                    Medical Use.
8-419............................  Standard Specification for Metal   ASTM F2885-11.
                                    Injection Molded Titanium-6
                                    Aluminum-4 Vanadium Components
                                    for Surgical Implant
                                    Applications.
8-420............................  Standard Specification for Metal   ASTM F2886-10.
                                    Injection Molded Cobalt-28
                                    Chromium-6 Molybdenum Components
                                    for Surgical Implant
                                    Applications.
----------------------------------------------------------------------------------------------------------------
                                                  I. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-100...........................  Ophthalmic optics--Contact lens    ISO 18259 First Edition 2014-10-01.
                                    care products--Method to assess
                                    contact lens care products with
                                    contact lenses in a lens case,
                                    challenged with bacterial and
                                    fungal organisms.
----------------------------------------------------------------------------------------------------------------
                                                  J. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-303...........................  Standard Guide for High Demand     ASTM F3047M-15.
                                    Hip Simulator Wear Testing of
                                    Hard-on-hard Articulations.

[[Page 19205]]

 
11-304...........................  Measuring Accuracy after           ASTM F3107-14.
                                    Mechanical Disturbances.
----------------------------------------------------------------------------------------------------------------
                                              K. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-196...........................  Wheelchairs--Part 7: Measurement   ISO 7176-7 First Edition 1998-05-15.
                                    of seating and wheel dimensions.
16-197...........................  Wheelchairs--Part 8: Requirements  ISO 7176-8 Second Edition 2014-12-15.
                                    and test methods for static,
                                    impact, and fatigue strengths.
16-198...........................  Wheelchairs--Part 22: Set-up       ISO 7176-22 Second Edition 2014-09-01.
                                    procedures.
----------------------------------------------------------------------------------------------------------------
                                             L. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-81............................  Health informatics--Personal       IEEE Std. 11073-10419: 2015.
                                    health device communication--
                                    Part 10419: Device
                                    Specialization--Insulin Pump.
----------------------------------------------------------------------------------------------------------------
                                                  M. Sterility
----------------------------------------------------------------------------------------------------------------
14-479...........................  Sterilization of health care       ANSI/AAMI/ISO 11135:2014.
                                    products--Ethylene oxide--
                                    Requirements for development,
                                    validation, and routine control
                                    of a sterilization process for
                                    medical devices.
----------------------------------------------------------------------------------------------------------------
                                              N. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-44............................  Standard Guide for in vivo         ASTM F2529-13.
                                    Evaluation of Osteoinductive
                                    Potential for Materials
                                    Containing Demineralized Bone
                                    (DBM) Active Standard.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA Recognized Consensus 
Standards in a searchable database that may be accessed directly at 
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications 
and revisions described in this notice into the database and, upon 
publication in the Federal Register, this recognition of consensus 
standards will be effective. FDA will announce additional modifications 
and revisions to the list of recognized consensus standards, as needed, 
in the Federal Register, once a year or more often if necessary. 
Beginning with Recognition List: 033, FDA no longer announces minor 
revisions to the list of recognized consensus standards such as 
technical contact person, devices affected, processes affected, Code of 
Federal Regulations citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the FD&C Act by submitting such 
recommendations, with reasons for the recommendation, to 
standards@cdrh.fda.gov. To be properly considered, such recommendations 
should contain, at a minimum, the following information: (1) Title of 
the standard, (2) any reference number and date, (3) name and address 
of the national or international standards development organization, 
(4) a proposed list of devices for which a declaration of conformity to 
this standard should routinely apply, and (5) a brief identification of 
the testing or performance or other characteristics of the device(s) 
that would be addressed by a declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. The Center for Devices and 
Radiological Health (CDRH) maintains a site on the Internet for easy 
access to information including text, graphics, and files that you may 
download to a personal computer with access to the Internet. Updated on 
a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices, 
includes a link to standards-related documents including the guidance 
and the current list of recognized standards. After publication in the 
Federal Register, this notice announcing ``Modification to the List of 
Recognized Standards, Recognition List Number: 041'' will be available 
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition 
and Use of Consensus Standards,'' and the searchable database for ``FDA 
Recognized Consensus Standards,'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

    Dated: March 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-07467 Filed 4-1-16; 8:45 am]
 BILLING CODE 4164-01-P


