[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