
[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Notices]
[Pages 41546-41553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15100]


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

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: 043

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) 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: 043'' (Recognition List Number: 043), 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 June 27, 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 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: 043.'' 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

[[Page 41547]]

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: 043.
     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: 043 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: 043 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: 043'' 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. 5514, 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 standard 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: 043

    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: 043'' 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 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
----------------------------------------------------------------------------------------------------------------
1-91...........................           1-116  ISO 5360 Fourth edition 2016-02-   Withdrawn and replaced with
                                                  15 Anaesthetic vaporizers--Agent   newer version.
                                                  specific filling systems.
----------------------------------------------------------------------------------------------------------------
                                                B. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-135..........................  ..............  ISO/TS 12417-1:2011                Withdrawn.
                                                  Cardiovascular implants and
                                                  extracorporeal systems--Vascular
                                                  device-drug combination products.

[[Page 41548]]

 
3-136..........................  ..............  AAMI/ANSI/ISO TIR 12417:2011       Withdrawn.
                                                  Cardiovascular implants and
                                                  extracorporeal systems--Vascular
                                                  device-drug combination products.
----------------------------------------------------------------------------------------------------------------
                                      C. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
4-86...........................  ..............  ANSI/ADA 38-2000 (R2015) Metal-    Reaffirmation.
                                                  Ceramic Systems.
4-139..........................  ..............  ANSI/ADA 48-2004 (R2015) Visible   Reaffirmation.
                                                  Light Curing Units.
4-146..........................           4-227  ISO 22674 Second edition. 2016-01- Withdrawn and replaced with
                                                  15 Dentistry--Metallic materials   newer version.
                                                  for fixed and removable
                                                  restorations and appliances.
4-166..........................           4-228  ANSI/ASA S3.20-2015 (Revision of   Withdrawn and replaced with
                                                  ANSI S3.20-1995) AMERICAN          newer version.
                                                  NATIONAL STANDARD: Bioacoustical
                                                  Terminology.
4-196..........................  ..............  ANSI/ADA 69-2010 (R2015) Dental    Reaffirmation.
                                                  Ceramics.
4-202..........................  ..............  ANSI/ADA 58-2010 (R2015) Root      Reaffirmation.
                                                  Canal Files, Type H (Hedstrom).
----------------------------------------------------------------------------------------------------------------
                             D. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-36...........................  ..............  ISO TR 16142 Second edition. 2006- Withdrawn. See 5-105.
                                                  1-15, Technical information
                                                  report: Medical devices--
                                                  Guidances on the selection of
                                                  standards in support of
                                                  recognized essential principles
                                                  of safety and performance of
                                                  medical devices.
5-40...........................  ..............  ISO 14971 Second edition. 2007-03- Relevant guidance.
                                                  01 Medical devices--Application
                                                  of risk management to medical
                                                  devices.
5-57...........................  ..............  AAMI/ANSI HE75:2009/(R)2013 Human  Relevant guidance.
                                                  factors engineering--Design of
                                                  medical devices.
5-67...........................  ..............  AAMI/ANSI/IEC 62366:2007/(R) 2013  Transition period.
                                                  Medical devices--Application of
                                                  usability engineering to medical
                                                  devices.
5-70...........................  ..............  AAMI/ANSI/ISO 14971:2007/(R) 2010  Relevant guidance.
                                                  (Corrected 4 October 2007)
                                                  Medical devices--Application of
                                                  risk management to medical
                                                  devices.
5-86...........................  ..............  IEC 60601-1-8 Edition 2.0. 2006-   Relevant guidance.
                                                  10 Medical electrical equipment--
                                                  Part 1-8: General requirements
                                                  for basic safety and essential
                                                  performance--Collateral
                                                  standard: General requirements,
                                                  tests and guidance for alarm
                                                  systems in medical electrical
                                                  equipment and medical electrical
                                                  systems.
5-87...........................  ..............  IEC 62366 Edition 1.1 2014-01      Transition period.
                                                  Medical devices--Application of
                                                  usability engineering to medical
                                                  devices.
5-89...........................  ..............  IEC 60601-1-6 Edition 3.1 2013-10  Relevant guidance.
                                                  Medical electrical equipment--
                                                  Part 1-6: General requirements
                                                  for basic safety and essential
                                                  performance--Collateral
                                                  standard: Usability.
5-92...........................  ..............  AAMI/ANSI/IEC 60601-1-8:2006 &     Relevant guidance.
                                                  A1:2012 Medical electrical
                                                  equipment--Part 1-8: General
                                                  requirements for basic safety
                                                  and essential performance--
                                                  Collateral standard: General
                                                  requirements, tests and guidance
                                                  for alarm systems in medical
                                                  electrical equipment and medical
                                                  electrical systems.
5-93...........................  ..............  AAMI CN3:2014 Small-bore           Withdrawn. See 5-106.
                                                  connectors for liquids and gases
                                                  in healthcare applications--Part
                                                  3: Connectors for enteral
                                                  applications.
5-95...........................  ..............  IEC 62366-1 Edition 1.0 2015-02    Transition period, Relevant
                                                  Medical devices--Part 1:           guidance.
                                                  Application of usability
                                                  engineering to medical devices.
5-96...........................  ..............  AAMI/ANSI/IEC 62366-1:2015         Transition period, Relevant
                                                  Medical devices--Part 1:           guidance.
                                                  Application of usability
                                                  engineering to medical devices.
5-101..........................  ..............  AAMI CN6:2015 Small-bore           Withdrawn. See 5-108.
                                                  connectors for liquids and gases
                                                  in healthcare applications--Part
                                                  6: Connectors for neuraxial
                                                  applications.
----------------------------------------------------------------------------------------------------------------
                    E. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-1...........................  ..............  IEC 60601-1-2 Edition 3. 2007-03,  Transition period.
                                                  Medical electrical equipment--
                                                  Part 1-2: General requirements
                                                  for basic safety and essential
                                                  performance--Collateral
                                                  standard: Electromagnetic
                                                  compatibility--Requirements and
                                                  tests.
19-2...........................  ..............  AAMI/ANSI/IEC 60601-1-2:2007/      Transition period.
                                                  (R)2012 Medical electrical
                                                  equipment--Part 1-2: General
                                                  requirements for basic safety
                                                  and essential performance--
                                                  Collateral standard:
                                                  Electromagnetic compatibility--
                                                  Requirements and tests.
19-6...........................  ..............  IEC 60601-1-11 Edition 1.0. 2010-  Relevant guidance.
                                                  04 Medical 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 [including:
                                                  Technical Corrigendum 1 (2011)].

[[Page 41549]]

 
19-7...........................  ..............  AAMI/ANSI HA 60601-1-11:2011       Relevant guidance.
                                                  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).
19-8...........................  ..............  IEC 60601-1-2 Edition 4.0. 2014-   Transition period.
                                                  02, Medical electrical
                                                  equipment--Part 1-2: General
                                                  requirements for basic safety
                                                  and essential performance--
                                                  Collateral standard:
                                                  Electromagnetic disturbances--
                                                  Requirements and tests.
19-12..........................  ..............  AAMI/ANSI/IEC 60601-1-2:2014,      Transition period.
                                                  Medical electrical equipment--
                                                  Part 1-2: General requirements
                                                  for basic safety and essential
                                                  performance--Collateral
                                                  standard: Electromagnetic
                                                  disturbances--Requirements and
                                                  tests.
19-14..........................  ..............  IEC 60601-1-11 Edition 2.0. 2015-  Relevant guidance.
                                                  01 Medical 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.
19-15..........................  ..............  IEC 60601-1-12 Edition 1.0. 2014-  Relevant guidance.
                                                  06 Medical electrical equipment--
                                                  Part 1-12: General requirements
                                                  for basic safety and essential
                                                  performance--Collateral
                                                  standard: Requirements for
                                                  medical electrical equipment and
                                                  medical electrical systems
                                                  intended for use in the
                                                  emergency medical services
                                                  environment.
----------------------------------------------------------------------------------------------------------------
                              F. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-15...........................           6-362  ISO/FDIS 7864 Fourth edition 2016- Withdrawn and replaced with
                                                  XX-XX Sterile hypodermic needles   newer version.
                                                  for single use--Requirements and
                                                  test methods.
6-132..........................           6-363  ISO 11810 Second edition 2015-12-  Withdrawn and replaced with
                                                  15 Lasers and laser-related        newer version.
                                                  equipment--Test method and
                                                  classification for the laser
                                                  resistance of surgical drapes
                                                  and/or patient protective
                                                  covers--Primary ignition,
                                                  penetration, flame spread and
                                                  secondary ignition.
6-145..........................  ..............  ASTM D3578--05 (Reapproved 2015)   Reaffirmation.
                                                  Standard Specification for
                                                  Rubber Examination Gloves.
6-168..........................  ..............  ASTM D3577--09 (Reapproved 2015)   Reaffirmation.
                                                  Standard Specification for
                                                  Rubber Surgical Gloves.
6-175..........................  ..............  ASTM D5151--06 (Reapproved 2015)   Reaffirmation.
                                                  Standard Test Method for
                                                  Detection of Holes in Medical
                                                  Gloves.
6-183..........................  ..............  ASTM D5250--06 (Reapproved 2015)   Reaffirmation.
                                                  Standard Specification for
                                                  Poly(vinyl chloride) Gloves for
                                                  Medical Application.
6-202..........................  ..............  ISO 11810-2 First edition. 2007-   Withdrawn. See 6-362.
                                                  05-01, Lasers and laser-related
                                                  equipment--Test method and
                                                  classification for the laser-
                                                  resistance of surgical drapes
                                                  and/or patient-protective
                                                  covers--Part 2: Secondary
                                                  ignition.
6-204..........................           6-364  ISO 8537 Third edition. 2016-03-   Withdrawn and replaced with
                                                  15 Sterile single-use syringes,    newer version.
                                                  with or without needle, for
                                                  insulin.
6-244..........................  ..............  ASTM D6319--10 (Reapproved 2015)   Reaffirmation.
                                                  Standard Specification for
                                                  Nitrile Examination Gloves for
                                                  Medical Application.
6-277..........................           6-365  ISO 11040-4 Third edition. 2015-   Withdrawn and replaced with
                                                  04-01 Prefilled syringes--Part     newer version.
                                                  4: Glass barrels for injectables
                                                  and sterilized subassembled
                                                  syringes ready for filling.
6-302..........................           6-366  ISO/FDIS 9626 Second edition 2016- Withdrawn and replaced with
                                                  XX-XX Stainless steel needle       newer version.
                                                  tubing for the manufacture of
                                                  medical devices--Requirements
                                                  and test methods.
6-343..........................           6-367  USP 39-NF 34:2016, Sodium          Withdrawn and replaced with
                                                  Chloride Irrigation.               newer version.
6-344..........................           6-368  USP 39-NF 34:2016, Sodium          Withdrawn and replaced with
                                                  Chloride Injection.                newer version.
6-345..........................           6-369  USP 39-NF 34:2016, Nonabsorbable   Withdrawn and replaced with
                                                  Surgical Suture.                   newer version.
6-346..........................           6-370  USP 39-NF 34:2016, <881> Tensile   Withdrawn and replaced with
                                                  Strength.                          newer version.
6-347..........................           6-371  USP 39-NF 34:2016, <861> Sutures-- Withdrawn and replaced with
                                                  Diameter.                          newer version.
6-348..........................           6-372  USP 39-NF 34:2016, <871> Sutures-- Withdrawn and replaced with
                                                  Needle Attachment.                 newer version.
6-349..........................           6-373  USP 39-NF 34:2016, Sterile Water   Withdrawn and replaced with
                                                  for Irrigation.                    newer version.

[[Page 41550]]

 
6-350..........................           6-374  USP 39-NF 34:2016, Heparin Lock    Withdrawn and replaced with
                                                  Flush Solution.                    newer version.
6-351..........................           6-375  USP 39-NF 34:2016, Absorbable      Withdrawn and replaced with
                                                  Surgical Suture.                   newer version.
----------------------------------------------------------------------------------------------------------------
                                          G. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-198..........................           7-261  CLSI M23 Development of In Vitro   Withdrawn and replaced with
                                                  Susceptibility Testing Criteria    newer version.
                                                  and Quality Control Parameters,
                                                  4th edition.
7-218..........................           7-262  CLSI M45 Methods for               Withdrawn and replaced with
                                                  Antimicrobial Dilution and Disk    newer version.
                                                  Susceptibility Testing of
                                                  Infrequently Isolated or
                                                  Fastidious Bacteria; Approved
                                                  Guideline, 3rd edition.
7-256..........................           7-263  CLSI M100-S26 Performance          Withdrawn and replaced with
                                                  Standards for Antimicrobial        newer version.
                                                  Susceptibility Testing, 26th
                                                  edition.
----------------------------------------------------------------------------------------------------------------
                                                  H. Materials
----------------------------------------------------------------------------------------------------------------
8-217..........................  ..............  ASTM F620-11(Reapproved 2015)      Reaffirmation.
                                                  Standard Specification for
                                                  Titanium Alloy Forgings for
                                                  Surgical Implants in the Alpha
                                                  Plus Beta Condition.
8-220..........................           8-421  ASTM F629-11 Standard Practice     Withdrawn and replaced with
                                                  for Radiography of Cast Metallic   newer version.
                                                  Surgical Implants.
8-381..........................           8-422  ASTM F2052-15 Standard Test        Withdrawn and replaced with
                                                  Method for Measurement of          newer version.
                                                  Magnetically Induced
                                                  Displacement Force on Medical
                                                  Devices in the Magnetic
                                                  Resonance Environment.
----------------------------------------------------------------------------------------------------------------
                                                  I. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-168.........................          11-305  ASTM F1781-15 Standard             Withdrawn and replaced with
                                                  Specification for Elastomeric      newer version.
                                                  Flexible Hinge Finger Total
                                                  Joint Implants.
11-171.........................          11-306  ASTM F1814-15 Standard Guide for   Withdrawn and replaced with
                                                  Evaluating Modular Hip and Knee    newer version.
                                                  Joint Components.
11-203.........................  ..............  ASTM F1541-02 (Reapproved 2015)    Reaffirmation.
                                                  Standard Specification and Test
                                                  Methods for External Skeletal
                                                  Fixation Devices.
11-271.........................  ..............  ASTM F2180-02 (Reapproved 2015)    Reaffirmation.
                                                  Standard Specification for
                                                  Metallic Implantable Strands and
                                                  Cables.
----------------------------------------------------------------------------------------------------------------
                                                  J. Radiology
----------------------------------------------------------------------------------------------------------------
12-153.........................          12-297  ANSI/IESNA RP-27.1-15 Recommended  Withdrawn and replaced with
                                                  Practice for Photobiological       newer version.
                                                  Safety for Lamps and Lamp
                                                  Systems--General requirements.
12-158.........................          12-298  NEMA MS 10-2010 Determination of   Withdrawn and replaced with
                                                  Local Specific Absorption Rate     newer version.
                                                  (SAR) in Diagnostic Magnetic
                                                  Resonance Imaging.
12-207.........................  ..............  IEC 60601-2-33 Ed. 3.0 2010        Transition period extended.
                                                  Medical electrical equipment--
                                                  Part 2-33: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of magnetic resonance equipment
                                                  for medical diagnosis.
12-209.........................  ..............  IEC 60601-2-37 Ed. 2.0:2007        Recognition restored with
                                                  Medical electrical equipment--     transition period.
                                                  Part 2-37: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of ultrasonic medical diagnostic
                                                  and monitoring equipment.
12-216.........................          12-299  IEC 62563-1 Ed.1.1 2016 Medical    Withdrawn and replaced with
                                                  electrical equipment--Medical      newer version with
                                                  image display systems--Part 1:     transition.
                                                  Evaluation methods.
12-236.........................  ..............  IEC 60601-2-45 Ed. 3.0: 2011       Recognition restored with
                                                  Medical electrical equipment--     transition period.
                                                  Part 2-45: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of mammographic X-ray equipment
                                                  and mammographic stereotactic
                                                  devices.
12-238.........................          12-300  NEMA Digital Imaging and           Withdrawn and replaced with
                                                  Communications in Medicine         newer version.
                                                  (DICOM) set PS3.1-3.20 (2016).
12-254.........................          12-301  IEC 60601-2-8 Ed. 2.1 b:2015       Withdrawn and replaced with
                                                  Medical electrical equipment--     newer version.
                                                  Part 2-8: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of therapeutic X-ray equipment
                                                  operating in the range 10 kV to
                                                  1 MV.
12-256.........................  ..............  IEC 60601-2-44 Ed. 3.1 2012        Transition extended.
                                                  Medical electrical equipment--
                                                  Part 2-44: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of X-ray equipment for computed
                                                  tomography.
12-257.........................  ..............  IEC 60601-2-44 Ed. 3.0 2009        Transition extended.
                                                  Medical electrical equipment--
                                                  Part 2-44: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of X-ray equipment for computed
                                                  tomography.
12-271.........................  ..............  IEC 60601-2-33 Ed. 3.1:2013        Recognition restored with
                                                  Medical electrical equipment--     transition period.
                                                  Part 2-33: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of magnetic resonance equipment
                                                  for medical diagnosis.

[[Page 41551]]

 
12-274.........................  ..............  IEC 60601-2-54 Ed. 1.0:2009        Recognition restored with
                                                  Medical electrical equipment--     transition period.
                                                  Part 2-54: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of X-ray equipment for
                                                  radiography and radioscopy
                                                  [Including: Technical
                                                  Corrigendum 1: 2010 and
                                                  Technical Corrigendum 2:2011].
12-293.........................  ..............  IEC 60601-2-37 Ed. 2.1:2015        Transition period.
                                                  Medical electrical equipment--
                                                  Part 2-37: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of ultrasonic medical diagnostic
                                                  and monitoring equipment.
12-294.........................  ..............  IEC 60601-2-45 Ed. 3.1: 2015       Transition period.
                                                  Medical electrical equipment--
                                                  Part 2-45: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of mammographic X-ray equipment
                                                  and mammographic stereotactic
                                                  devices.
12-295.........................  ..............  IEC 60601-2-33 Ed. 3.2 b:2015      Transition period extended.
                                                  Medical electrical equipment--
                                                  Part 2-33: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of magnetic resonance equipment
                                                  for medical diagnosis.
12-296.........................  ..............  IEC 60601-2-54 Ed. 1.1:2015        Transition period.
                                                  Medical electrical equipment--
                                                  Part 2-54: Particular
                                                  requirements for the basic
                                                  safety and essential performance
                                                  of X-ray equipment for
                                                  radiography and radioscopy.
----------------------------------------------------------------------------------------------------------------
                                                  K. Sterility
----------------------------------------------------------------------------------------------------------------
14-139.........................          14-479  ISO 14644-1 Second edition 2015-   Withdrawn and replaced with
                                                  12-15 Cleanrooms and associated    newer version.
                                                  controlled environments--Part 1:
                                                  Classification of air
                                                  cleanliness by particle
                                                  concentration.
14-140.........................          14-481  ISO 14644-2 Second edition 2015-   Withdrawn and replaced with
                                                  12-15 Cleanrooms and associated    newer version.
                                                  controlled environments--Part 2:
                                                  Monitoring to provide evidence
                                                  of cleanroom performance related
                                                  to air cleanliness by particle
                                                  concentration.
14-283.........................          14-482  ASTM F88/F88M--15 Standard Test    Withdrawn and replaced with
                                                  Method for Seal Strength of        newer version.
                                                  Flexible Barrier Materials.
14-341.........................          14-483  ISO/ASTM 52303 First edition 2015- Withdrawn and replaced with
                                                  07-15 Guide for absorbed-dose      newer version.
                                                  mapping in radiation processing
                                                  facilities.
14-344.........................  ..............  ASTM F2825--10 (Reapproved 2015)   Reaffirmation.
                                                  Standard Practice for Climatic
                                                  Stressing of Packaging Systems
                                                  for Single Parcel Delivery.
14-378.........................          14-484  ASTM F1929--15 Standard Test       Withdrawn and replaced with
                                                  Method for Detecting Seal Leaks    newer version.
                                                  in Porous Medical Packaging by
                                                  Dye Penetration.
14-466.........................          14-485  USP 39-NF34:2016 <61>              Withdrawn and replaced with
                                                  Microbiological Examination of     newer version.
                                                  Nonsterile Products: Microbial
                                                  Enumeration Tests.
14-467.........................          14-486  USP 39-NF34:2016 <71> Sterility    Withdrawn and replaced with
                                                  Tests.                             newer version.
14-468.........................          14-487  USP 39-NF34:2016 <85> Bacterial    Withdrawn and replaced with
                                                  Endotoxins Test.                   newer version.
14-469.........................          14-488  USP 39-NF34:2016 <161> Medical     Withdrawn and replaced with
                                                  Devices-Bacterial Endotoxin and    newer version.
                                                  Pyrogen Tests.
14-470.........................          14-489  USP 39-NF34:2016 Biological        Withdrawn and replaced with
                                                  Indicator for Steam                newer version.
                                                  Sterilization, Self Contained.
14-471.........................          14-490  USP 39-NF34:2016 Biological        Withdrawn and replaced with
                                                  Indicator for Dry-Heat             newer version.
                                                  Sterilization, Paper Carrier.
14-472.........................          14-491  USP 39-NF34:2016 Biological        Withdrawn and replaced with
                                                  Indicator for Ethylene Oxide       newer version.
                                                  Sterilization, Paper Carrier.
14-473.........................          14-492  USP 39-NF34:2016 Biological        Withdrawn and replaced with
                                                  Indicator for Steam                newer version.
                                                  Sterilization, Paper Carrier.
14-474.........................          14-493  USP 39-NF34:2016 <62>              Withdrawn and replaced with
                                                  Microbiological Examination of     newer version.
                                                  Nonsterile Products: Tests for
                                                  Specified Microorganisms.
14-475.........................          14-494  USP 39-NF34:2016 <55> Biological   Withdrawn and replaced with
                                                  Indicators--Resistance             newer version.
                                                  Performance Tests.
14-476.........................          14-495  USP 39-NF34:2016 <1035>            Withdrawn and replaced with
                                                  Biological Indicators for          newer version.
                                                  Sterilization.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

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: 043.

[[Page 41552]]



        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                          Reference No.
        Recognition No.          Title of standard \1\      and date
------------------------------------------------------------------------
                            A. Cardiovascular
------------------------------------------------------------------------
3-142.........................  Cardiovascular          ISO/TS
                                 implants and            17137:2014.
                                 extracorporeal
                                 systems--Cardiovascul
                                 ar absorbable
                                 implants.
3-143.........................  Cardiovascular          ISO 12417 First
                                 implants and            edition 2015-10-
                                 extracorporeal          01.
                                 systems--Vascular
                                 device-drug
                                 combination products.
------------------------------------------------------------------------
         B. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-105.........................  Medical devices--       ISO 16142-1
                                 Recognized essential    First edition
                                 principles of safety    2016-03-01.
                                 and performance of
                                 medical devices--Part
                                 1: General essential
                                 principles and
                                 additional specific
                                 essential principles
                                 for all non-IVD
                                 medical devices and
                                 guidance on the
                                 selection of
                                 standards.
5-106.........................  Small-bore connectors   ISO/FDIS 80369-3
                                 for liquids and gases   First edition
                                 in healthcare           2016-02-04.
                                 applications--Part 3:
                                 Connectors for
                                 enteral applications.
5-107.........................  Small-bore connectors   IEC 80369-5:
                                 for liquids and gases   Edition 1.0
                                 in healthcare           2016-03.
                                 applications--Part 5:
                                 Connectors for limb
                                 cuff inflation
                                 applications.
5-108.........................  Small bore connectors   ISO 80369-6
                                 for liquids and gases   First edition.
                                 in healthcare           2016-03-15.
                                 applications--Part 6:
                                 Connectors for
                                 neuraxial
                                 applications.
------------------------------------------------------------------------
          C. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
6-376.........................  Hypodermic needles for  ISO/FDIS 6009
                                 single use--Colour      Fourth edition
                                 coding for              2016-01-18.
                                 identification.
6-377.........................  Needle-based injection  ISO 11608-5
                                 systems for medical     First edition
                                 use--Requirements and   2012-10-01.
                                 test methods--Part 5:
                                 Automated functions.
6-378.........................  Needle-based injection  ISO/FDIS 11608-7
                                 systems for medical     First edition
                                 use--Requirements and   2016-06-16.
                                 test methods--Part 7:
                                 Accessibility for
                                 persons with visual
                                 impairment.
------------------------------------------------------------------------
                         D. In Vitro Diagnostic
------------------------------------------------------------------------
7-264.........................  Genomic Copy Number     MM21- Ed. 1.
                                 Microarrays for
                                 Constitutional
                                 Genetic and Oncology
                                 Applications, 1st
                                 edition.
------------------------------------------------------------------------
                              E. Materials
------------------------------------------------------------------------
8-423.........................  Standard Guide for      ASTM F2565-13.
                                 Extensively
                                 Irradiation-
                                 Crosslinked Ultra-
                                 High Molecular Weight
                                 Polyethylene
                                 Fabricated Forms for
                                 Surgical Implant
                                 Applications.
8-424.........................  Standard Specification  ASTM F2695-12.
                                 for Ultra-High
                                 Molecular Weight
                                 Polyethylene Powder
                                 Blended With Alpha-
                                 Tocopherol (Vitamin
                                 E) and Fabricated
                                 Forms for Surgical
                                 Implant Applications.
8-425.........................  Standard Specification  ASTM F2820-12.
                                 for
                                 Polyetherketoneketone
                                 (PEKK) Polymers for
                                 Surgical Implant
                                 Applications.
8-426.........................  Standard Specification  ASTM F3087-15.
                                 for Acrylic Molding
                                 Resins for Medical
                                 Implant Applications.
8-427.........................  Standard Specification  ASTM F1185-03
                                 for Composition of      (Reapproved
                                 Hydroxylapatite for     2014).
                                 Surgical Implants.
8-428.........................  Standard Specification  ASTM F1581-08
                                 for Composition of      (Reapproved
                                 Anorganic Bone for      2012).
                                 Surgical Implants.
8-429.........................  Standard Specification  ASTM F2224-09
                                 for High Purity         (Reapproved
                                 Calcium Sulfate         2014).
                                 Hemihydrate or
                                 Dihydrate for
                                 Surgical Implants.
8-430.........................  Implants for surgery--  ISO 13356:2015
                                 Ceramic materials       Third edition.
                                 based on yttria-        2015-09-15.
                                 stabilized tetragonal
                                 zirconia (Y-TZP).
8-431.........................  Standard Practice for   ASTM F2971-13.
                                 Reporting Data for
                                 Test Specimens
                                 Prepared by Additive
                                 Manufacturing.
8-432.........................  Standard Terminology    ISO/ASTM 52921-
                                 for Additive            13 First
                                 Manufacturing-          edition 2013-06-
                                 Coordinate Systems      01.
                                 and Test
                                 Methodologies.
8-434.........................  Additive                ISO/ASTM 52900
                                 manufacturing--Genera   First edition
                                 l principles--          2015-12-15.
                                 Terminology.
------------------------------------------------------------------------
                              F. Orthopedic
------------------------------------------------------------------------
11-307........................  Standard Practice for   ASTM F2385-15.
                                 Determining Femoral
                                 Head Penetration into
                                 Acetabular Components
                                 of Total Hip
                                 Replacement Using
                                 Clinical Radiographs.
11-308........................  Standard Test Method    ASTM F3161-16.
                                 for Finite Element
                                 Analysis (FEA) of
                                 Metallic Orthopaedic
                                 Total Knee Femoral
                                 Components under
                                 Closing Conditions.
11-309........................  Standard Specification  ASTM F116-12.
                                 for Medical
                                 Screwdriver Bits.
11-310........................  Standard Specification  ASTM F1611-00
                                 for Intramedullary      (Reapproved
                                 Reamers.                2013).
------------------------------------------------------------------------
                              G. Radiology
------------------------------------------------------------------------
12-302........................  Medical electrical      IEC 60601-2-44
                                 equipment--Part 2-44:   Ed. 3.2:2016.
                                 Particular
                                 requirements for the
                                 basic safety and
                                 essential performance
                                 of X-ray equipment
                                 for computed
                                 tomography.
------------------------------------------------------------------------

[[Page 41553]]

 
                         H. Software/Informatics
------------------------------------------------------------------------
13-82.........................  Application of risk     AAMI/ISO TIR
                                 management for IT       80001-2-6:2014.
                                 networks
                                 incorporating
                                 medical--Application
                                 guidance--Part 2-6:
                                 Guidance for
                                 responsibility
                                 agreements.
13-83.........................  Principles for medical  AAMI TIR
                                 device security--Risk   57:2016.
                                 management.
13-84.........................  Health informatics--    ISO/IEEE 11073-
                                 Point-of-care medical   10103 First
                                 device communication--  edition 2014-03-
                                 Part 10103:             01.
                                 Nomenclature--Implant
                                 able device, cardiac.
------------------------------------------------------------------------
                          I. Tissue Engineering
------------------------------------------------------------------------
15-45.........................  Medical devices         ISO 22442-1
                                 utilizing animal        Second edition
                                 tissues and their       2015-11-1.
                                 derivatives--Part 1:
                                 Application of risk
                                 management.
15-46.........................  Medical devices         ISO 22442-2
                                 utilizing animal        Second edition
                                 tissues and their       2015-11-1.
                                 derivatives--Part 2:
                                 Controls on sourcing,
                                 collection and
                                 handling.
15-47.........................  Medical devices         ISO 22442-3
                                 utilizing animal        First edition
                                 tissues and their       2007-12-15.
                                 derivatives--Part 3:
                                 Validation of the
                                 elimination and/or
                                 inactivation of
                                 viruses and
                                 transmissible
                                 spongiform
                                 encephalopathy (TSE)
                                 agents.
------------------------------------------------------------------------
\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: 043'' 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: June 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-15100 Filed 6-24-16; 8:45 am]
 BILLING CODE 4164-01-P


