
[Federal Register Volume 82, Number 110 (Friday, June 9, 2017)]
[Notices]
[Pages 26807-26810]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12007]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2901]


Medical Devices; Validated Instructions for Use and Validation 
Data Requirements for Certain Reusable Medical Devices in Premarket 
Notifications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has 
determined that it is necessary for manufacturers of certain reusable 
medical devices to include in their premarket notifications (510(k)s) 
instructions for use which have been validated and validation data 
regarding cleaning, disinfection, and sterilization, for which a 
substantial equivalence determination may be based. This notice 
includes a list of these reusable devices that will require validated 
instructions for use and validation data in their premarket 
notification. FDA is publishing this list in accordance with the 
requirements established by the 21st Century Cures Act. This action 
ensures that the premarket requirements for these device types are 
clear and predictable which facilitates more efficient review of these 
510(k)s.

DATES: These actions are effective on August 8, 2017.

FOR FURTHER INFORMATION CONTACT: Constance Soves, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1437, Silver Spring, MD 20993-0002, 301-
796-6951.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
301 et seq.), as amended, established a comprehensive system for the 
regulation of medical devices intended for human use. Section 513 of 
the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of 
devices, based on the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness. The three categories of 
devices are class I (general controls), class II (special controls), 
and class III (premarket approval).
    Devices introduced into interstate commerce for the first time on 
or after May 28, 1976 (generally referred to as post-amendments 
devices), are classified automatically by statute (section 513(f) of 
the FD&C Act) into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless FDA 
initiates one of the following procedures: (1) FDA reclassifies the 
device into class I or II; (2) FDA issues an order classifying the 
device into class I or II in accordance with section 513(f)(2) of the 
FD&C Act; or (3) FDA issues an order finding the device to be 
substantially equivalent, under section 513(i), to a predicate device 
that is already legally marketed. The Agency determines whether new 
devices are substantially equivalent to predicate devices through 
review of premarket notifications under section 510(k) of the FD&C Act 
(21 U.S.C. 360(k)). Section 510(k) of the FD&C Act and its implementing 
regulations, codified in Title 21 of the Code of Federal Regulations 
(21 CFR part 807, subpart E), require persons who intend to market a 
new device that does not require a premarket approval application under 
section 515 of the FD&C Act (21 U.S.C. 360e) to submit a premarket 
notification report (510(k)) containing information that allows FDA to 
determine whether the new device is ``substantially equivalent'' within 
the meaning of section 513(i) of the FD&C Act to a legally marketed 
device that does not require premarket approval.
    On December 13, 2016, the President signed into law the 21st 
Century Cures Act (Pub. L. 114-255) (Ref. 1). Section 3059 of the 21st 
Century Cures Act, in part, amends section 510 of the FD&C Act to 
require FDA to publish in the Federal Register a notice identifying a 
list of reusable device types that must include validated instructions 
for use and validation data regarding cleaning, disinfection, and 
sterilization in their 510(k) submissions. This section also

[[Page 26808]]

provides that a 510(k) submission for a reusable device may not be 
substantially equivalent to a predicate device if the validated 
instructions for use and reprocessing validation data submitted as part 
of the 510(k) are inadequate.
    Manufacturers of reusable medical devices are responsible for 
having labeling that bears adequate directions for use, including 
instructions on preparing a device for use under 21 CFR 801.5 and 
801.109. However, in recent years, there have been significant changes 
in knowledge and technology involved in reprocessing reusable medical 
devices. Additionally, there has been an evolution towards more complex 
reusable medical device designs that are more difficult to clean, 
disinfect, and sterilize. FDA believes reusable devices must be 
designed for adequate reprocessing and safe reuse, with comprehensive 
and clear instructions for effective reprocessing procedures for use by 
health care facilities that reprocess these devices.

II. Requirements for Validated Reprocessing Instructions and 
Reprocessing Validation Data for Reusable Medical Devices

    A reusable medical device is one intended for repeated use either 
on the same or different patients, with appropriate cleaning and other 
reprocessing steps between uses. FDA has issued recommendations for 
reprocessing reusable devices in relevant documents, including the FDA 
guidance ``Reprocessing Medical Devices in Health Care Settings: 
Validation Methods and Labeling,'' as information on the reprocessing 
validation methods necessary to be reported in a 510(k) submission 
(Ref. 2). FDA expects specific required validation data regarding 
cleaning, disinfection, and sterilization to be included in 510(k) 
submissions for certain reusable medical device types as outlined in 
tables 1 and 2 below.
    FDA believes that a majority of manufacturers for the reusable 
devices listed below are already conducting validation of their 
reprocessing instructions because FDA already has provided 
recommendations for reprocessing validation in relevant FDA documents. 
Sponsors of new 510(k) notifications for reusable devices identified in 
the tables below must also include validation data regarding cleaning, 
disinfection, and sterilization, in addition to all the other required 
elements of a 510(k) identified in 21 CFR 807.87, starting on August 8, 
2017.

III. List of Certain Reusable Medical Devices and Design Features

    The 21st Century Cures Act (section 3059) requires the Agency to 
identify and publish a list of reusable device types that are required 
to include ``instructions for use'' and ``validation data'' regarding 
cleaning, disinfection, and sterilization in 510(k) notifications. 
Accordingly, FDA is publishing the list in table 1 that identifies 
those reusable medical devices that FDA has determined pose a greater 
likelihood of microbial transmission and represent a high risk of 
infection (subclinical or clinical) if they are not adequately 
reprocessed.
    FDA believes arthroscopes, laparoscopic instruments, and 
electrosurgical instruments, and their respective accessories with 
specific design features, identified in table 2, may pose a challenge 
to adequate reprocessing. 510(k) notifications for such devices that 
incorporate any of the design features listed in table 2 must include 
validated reprocessing instructions and reprocessing validation data 
reports, and if such are determined to be inadequate, FDA will find the 
device not substantially equivalent.

  Table 1--Reusable Devices That Require Validation Data and Validated Reprocessing Instructions Be Included in
                  510(k) Notification and Upon Which FDA Will Determine Substantial Equivalence
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             Device type                 Product code           Device name               21 CFR section
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Bronchoscopes (flexible or rigid)     EOQ                 Bronchoscope (flexible  21 CFR 874.4680
 and accessories.                     PSV                  or rigid).             21 CFR 892.1550
                                                          Ultrasound
                                                           bronchoscope.
                                      KTI                 Bronchoscope accessory  21 CFR 874.4680
                                      BTG                 Brush, biopsy,          21 CFR 874.4680
                                                           bronchoscope (non-
                                                           rigid).
                                      JEI                 Claw, foreign body,     21 CFR 874.4680
                                                           bronchoscope (non-
                                                           rigid).
                                      JEL                 Curette, biopsy,        21 CFR 874.4680
                                                           bronchoscope (rigid).
                                      BST                 Curette, biopsy,        21 CFR 874.4680
                                                           bronchoscope (non-
                                                           rigid).
                                      BWH                 Forceps, biopsy,        21 CFR 874.4680
                                                           bronchoscope (non-
                                                           rigid).
                                      JEK                 Forceps, biopsy,        21 CFR 874.4680
                                                           bronchoscope (rigid).
                                      ENZ                 Telescope, laryngeal-   21 CFR 874.4680
                                                           bronchial.
                                      KTR                 Tube, aspirating,       21 CFR 874.4680
                                                           bronchoscope (rigid).
                                      JEJ                 Tubing,                 21 CFR 874.4680
                                                           Instrumentation,
                                                           bronchoscope (brush
                                                           sheath A/O
                                                           aspirating).
Ear, Nose, and Throat (ENT)           EOX                 Esophagoscope           21 CFR 874.4710
 endoscopes and accessories.          GCL                  (flexible or rigid).   21 CFR 876.1500
                                                          Esophagoscope, general
                                                           & plastic surgery.
                                      FDW                 Esophagoscope, rigid,   21 CFR 876.1500
                                                           gastro-urology.
                                      EOB                 Nasopharyngoscope       21 CFR 874.4760
                                                           (flexible or rigid).
                                      EQN                 Laryngoscope,           21 CFR 874.4760
                                                           nasopharyngoscope.
                                      EWY                 Mediastinoscope,        21 CFR 874.4720
                                                           surgical, and
                                                           accessories.
Gastroenterology and Urology          FDT                 Duodenoscope and        21 CFR 876.1500
 Endoscopes that have elevator        FAK                  accessories, flexible/ 21 CFR 876.1500
 channels (not including              ODF                  rigid.                 21 CFR 876.1500
 accessories).                                            Panendoscope
[e.g., duodenoscopes used for                              (gastroduodenoscope).
 endoscopic retrograde                                    Mini endoscope,
 cholangiopancreatography (ERCP)].                         gastroenterology-
                                                           urology.
Automated Reprocessors for Reusable   FEB                 Accessories, cleaning,  21 CFR 876.1500
 Devices.                             NZA                  for endoscopes.        21 CFR 876.1500
                                                          Accessories,
                                                           germicide, cleaning,
                                                           for endoscopes.
                                      OUJ                 High level              21 CFR 892.1570
                                                           disinfection
                                                           reprocessing
                                                           instrument for
                                                           ultrasonic
                                                           transducers, mist.
                                      NVE                 Washer, cleaner,        21 CFR 876.1500
                                                           automated, endoscope.
                                      PSW                 High level              21 CFR 892.1570
                                                           disinfection
                                                           reprocessing
                                                           instrument for
                                                           ultrasonic
                                                           transducers, liquid.

[[Page 26809]]

 
Other Flexible Gastroenterology and   FDF                 Colonoscope and         21 CFR 876.1500
 Urology Endoscopes \1\ (not          FBN                  accessories, flexible/ 21 CFR 876.1500
 including accessories).                                   rigid.
                                                          Choledochoscope and
                                                           accessories, flexible/
                                                           rigid.
                                      FDA                 Enteroscope and         21 CFR 876.1500
                                                           accessories.
                                      FDS                 Gastroscope and         21 CFR 876.1500
                                                           accessories, flexible/
                                                           rigid.
                                      FAJ                 Cystoscope and          21 CFR 876.1500
                                                           accessories, flexible/
                                                           rigid.
                                      FGB                 Ureteroscope and        21 CFR 876.1500
                                                           accessories, flexible/
                                                           rigid.
                                      ODG                 Endoscopic ultrasound   21 CFR 876.1500
                                                           system,
                                                           gastroenterology-
                                                           urology.
Neurological endoscopes (not          GWG                 Endoscope,              21 CFR 882.1480
 including accessories).                                   neurological.
Water-based heater-cooler systems     DWC                 Controller,             21 CFR 870.4250
 for use in operating rooms.          DWJ                  Temperature,           21 CFR 870.5900
                                                           Cardiopulmonary
                                                           Bypass.
                                                          System, Thermal
                                                           Regulating.
System, Surgical, Computer            NAY                 System, Surgical,       21 CFR 876.1500
 Controlled Instrument.                                    Computer Controlled
                                                           Instrument.
Arthroscopes and accessories \2\....  HRX                 Arthroscope...........  21 CFR 888.1100
Laparoscopic instruments and          GCJ                 Laparoscope, general    21 CFR 876.1500
 accessories \2\.                                          and plastic surgery.
Electrosurgical instruments and       GEI                 Electrosurgical,        21 CFR 878.4400
 accessories \2\.                                          cutting and
                                                           coagulation and
                                                           accessories.
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\1\ For endoscopes that fall under these product codes, 510(k) submissions must include reprocessing validation
  data for those endoscopes which are flexible.
\2\ For devices that fall under these product codes, 510(k) submissions must include reprocessing validation
  data if the device possesses any of the design features listed in table 2 below.


     Table 2--Design Features Which May Pose a Challenge to Adequate
      Reprocessing for Arthroscopes, Laparoscopic Instruments, and
      Electrosurgical Instruments, and Their Respective Accessories
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Lumens (especially lumens of flexible design, multiple internal lumens,
 lumens that are not freely accessible, bifurcated lumens, lumens with
 internal surfaces that are not smooth, have internal ridges or sharp
 angles, or are too small to permit a brush to pass through).
Hinges, depressions, joints with gaps, overlapping or butted joints that
 result in acute angles, or ribbed or otherwise ``roughened'' surfaces
 (e.g., jaws).
Interior device channels.
Sleeves surrounding rods, blades, activators, inserters, etc.
Shafts within lumens.
Adjacent device surfaces between which debris can be forced or caught
 during use.
O-rings.
Stopcocks/Valves.
Crevices.
Fittings with very close tolerances.
Clamps that cannot be fully opened for cleaning.
Small internal parts (e.g., springs, magnets, etc.) that may become
 soiled.
Ridges, articulations or grooves.
Rough, irregular, discontinuous surfaces that can entrap or retain soil.
Capillary gaps.
Luer locks.
Porous materials (smooth surfaces are desirable, where possible).
Junctions between insulating sheaths and activating mechanisms (as in
 certain laparoscopic instruments).
Dead-ended chambers.
Internal movable device components such as multiple cables.
Device features that may entrap debris that can later become aerosolized
 (e.g., through application of power, etc.).
Devices with these or other design features that cannot be disassembled
 for reprocessing.
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    The Agency believes that these devices currently have the greatest 
risk of infection transmission and inadequate performance if not 
adequately reprocessed. In the future, the Agency may reevaluate and 
revise both tables as it deems necessary.

IV. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in part 801 have been approved under OMB 
control number 0910-0485 (medical device labeling); the collections of 
information in part 807, subpart E have been approved under OMB control 
number 0910-0120 (premarket notification); and the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073 (quality system regulation).

V. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. 21st Century Cures Act, Public Law 114-255, available at https://www.congress.gov/114/bills/hr34/BILLS-114hr34eah.pdf.
2. FDA's Guidance, Reprocessing Medical Devices in Health Care 
Settings: Validation Methods and Labeling, March 2015, available at 
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf.


[[Page 26810]]


    Dated: June 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12007 Filed 6-8-17; 8:45 am]
 BILLING CODE 4164-01-P


