Medical Devices; Validated Instructions for Use and Validation Data Requirements for Certain Reusable Medical Devices in Premarket Notifications, 26807-26810 [2017-12007]
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Federal Register / Vol. 82, No. 110 / Friday, June 9, 2017 / Notices
Location
Grantee
New York, NY ...........................................
New York, NY ...........................................
New York, NY ...........................................
Yonkers, NY ..............................................
Yonkers, NY ..............................................
U.S. Multi-City ...........................................
U.S. Multi-City ...........................................
Cayuga Home for Children DBA Cayuga Centers ......................................................
Cayuga Home for Children DBA Cayuga Centers ......................................................
Catholic Guardian Services .........................................................................................
Leake and Watts Services, Inc ....................................................................................
Leake and Watts Services, Inc ....................................................................................
Southwest Keys, Inc ....................................................................................................
Southwest Keys, Inc ....................................................................................................
mstockstill on DSK30JT082PROD with NOTICES
ORR is continuously monitoring its
capacity to provide post-release services
to the unaccompanied alien children in
HHS custody. ORR has specific
requirements for the provision of
services. Award recipients must have
the infrastructure, licensing, experience,
and appropriate level of trained staff to
meet those requirements. The expansion
of the existing post-release services
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award is a key strategy for ORR to be
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safe and timely release of
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illegal migration, trafficking, and protect
the borders of the United States.
Statutory Authority: This program is
authorized by—
(A) Section 462 of the Homeland
Security Act of 2002, which in March
2003, transferred responsibility for the
care and custody of Unaccompanied
Alien Children from the Commissioner
of the former Immigration and
Naturalization Service (INS) to the
Director of ORR of the Department of
Health and Human Services (HHS).
(B) The Flores Settlement Agreement,
Case No. CV85–4544RJK (C.D. Cal.
1996), as well as the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008
(Pub. L. 110–457), which authorizes
post release services under certain
conditions to eligible children. All
programs must comply with the Flores
Settlement Agreement, Case No. CV85–
4544–RJK (C.D. Cal. 1996), pertinent
regulations and ORR policies and
procedures.
Elizabeth Leo,
Grants Policy Specialist, Division of Grants
Policy, Office of Administration,
Administration for Children and Families.
[FR Doc. 2017–11940 Filed 6–8–17; 8:45 am]
BILLING CODE 4184–45–P
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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.
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:
SUMMARY:
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
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26807
Amount
5,404,388
1,052,501
1,664,514
1,804,974
473,826
10,257,820
1,330,080
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
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26808
Federal Register / Vol. 82, No. 110 / Friday, June 9, 2017 / Notices
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
Product
code
Device type
EOQ
PSV
KTI
BTG
JEI
JEL
BST
BWH
JEK
ENZ
KTR
JEJ
Ear, Nose, and Throat (ENT) endoscopes and accessories.
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Bronchoscopes (flexible or rigid) and accessories ....
EOX
GCL
FDW
EOB
EQN
EWY
FDT
FAK
ODF
Gastroenterology and Urology Endoscopes that
have elevator channels (not including accessories).
[e.g., duodenoscopes used for endoscopic retrograde cholangiopancreatography (ERCP)].
Automated Reprocessors for Reusable Devices ......
FEB
NZA
OUJ
NVE
PSW
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Device name
21 CFR section
Bronchoscope (flexible or rigid) .........................................
Ultrasound bronchoscope ..................................................
Bronchoscope accessory ...................................................
Brush, biopsy, bronchoscope (non-rigid) ...........................
Claw, foreign body, bronchoscope (non-rigid) ...................
Curette, biopsy, bronchoscope (rigid) ................................
Curette, biopsy, bronchoscope (non-rigid) .........................
Forceps, biopsy, bronchoscope (non-rigid) ........................
Forceps, biopsy, bronchoscope (rigid) ...............................
Telescope, laryngeal-bronchial ..........................................
Tube, aspirating, bronchoscope (rigid) ..............................
Tubing, Instrumentation, bronchoscope (brush sheath A/
O aspirating).
Esophagoscope (flexible or rigid) .......................................
Esophagoscope, general & plastic surgery .......................
Esophagoscope, rigid, gastro-urology ................................
Nasopharyngoscope (flexible or rigid) ...............................
Laryngoscope, nasopharyngoscope ..................................
Mediastinoscope, surgical, and accessories ......................
Duodenoscope and accessories, flexible/rigid ...................
Panendoscope (gastroduodenoscope) ..............................
Mini endoscope, gastroenterology-urology ........................
Accessories, cleaning, for endoscopes ..............................
Accessories, germicide, cleaning, for endoscopes ............
High level disinfection reprocessing instrument for ultrasonic transducers, mist.
Washer, cleaner, automated, endoscope ..........................
High level disinfection reprocessing instrument for ultrasonic transducers, liquid.
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21
21
21
21
21
21
21
21
21
21
21
21
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
874.4680
892.1550
874.4680
874.4680
874.4680
874.4680
874.4680
874.4680
874.4680
874.4680
874.4680
874.4680
21
21
21
21
21
21
21
21
21
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
874.4710
876.1500
876.1500
874.4760
874.4760
874.4720
876.1500
876.1500
876.1500
21 CFR 876.1500
21 CFR 876.1500
21 CFR 892.1570
21 CFR 876.1500
21 CFR 892.1570
26809
Federal Register / Vol. 82, No. 110 / Friday, June 9, 2017 / Notices
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—Continued
Product
code
Device type
Other Flexible Gastroenterology and Urology
Endoscopes 1 (not including accessories).
Neurological endoscopes (not including accessories)
Water-based heater-cooler systems for use in operating rooms.
System, Surgical, Computer Controlled Instrument ..
Arthroscopes and accessories 2 ................................
Laparoscopic instruments and accessories 2 ............
Electrosurgical instruments and accessories 2 ..........
Device name
FDF
FBN
FDA
FDS
FAJ
FGB
ODG
GWG
DWC
DWJ
NAY
HRX
GCJ
GEI
21 CFR section
Colonoscope and accessories, flexible/rigid ......................
Choledochoscope and accessories, flexible/rigid ..............
Enteroscope and accessories ............................................
Gastroscope and accessories, flexible/rigid .......................
Cystoscope and accessories, flexible/rigid ........................
Ureteroscope and accessories, flexible/rigid .....................
Endoscopic ultrasound system, gastroenterology-urology
Endoscope, neurological ....................................................
Controller, Temperature, Cardiopulmonary Bypass ...........
System, Thermal Regulating ..............................................
System, Surgical, Computer Controlled Instrument ...........
Arthroscope ........................................................................
Laparoscope, general and plastic surgery .........................
Electrosurgical, cutting and coagulation and accessories
21
21
21
21
21
21
21
21
21
21
21
21
21
21
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
CFR
876.1500
876.1500
876.1500
876.1500
876.1500
876.1500
876.1500
882.1480
870.4250
870.5900
876.1500
888.1100
876.1500
878.4400
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
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.
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.
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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
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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
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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/BILLS114hr34eah.pdf.
2. FDA’s Guidance, Reprocessing Medical
Devices in Health Care Settings:
Validation Methods and Labeling, March
2015, available at https://www.fda.gov/
downloads/medicaldevices/
deviceregulationandguidance/
guidancedocuments/ucm253010.pdf.
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Federal Register / Vol. 82, No. 110 / Friday, June 9, 2017 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; Information
Collection Request Title: Title V
Maternal and Child Health Services
Block Grant to States Program:
Guidance and Forms for the Title V
Application/Annual Report OMB No.
0915–0172—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than August 8, 2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference, in compliance with Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995.
Information Collection Request Title:
Title V Maternal and Child Health
Services Block Grant to States Program:
Guidance and Forms for the Title V
Application/Annual Report, OMB No.
0915–0172—Revision
Abstract: HRSA is updating the Title
V Maternal and Child Health Services
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SUMMARY:
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Block Grant to States Program:
Guidance and Forms for the Title V
Application/Annual Report. This
guidance is used annually by the 50
states and 9 jurisdictions (hereafter
state) in applying for Block Grants
under Title V of the Social Security Act
and in preparing the required annual
report. The updates proposed by
HRSA’s Maternal and Child Health
Bureau (MCHB) for this edition of the
guidance are intended to reinforce the
role of the state in developing a Title V
Maternal and Child Health (MCH)
Action Plan that addresses its priority
needs. These proposed updates further
refine the reporting structure and vision
that was outlined in the previous
edition. As such, they are intended to
enable a state to articulate its Title V
program activities and leadership efforts
for serving the MCH population. The
proposed updates to the guidance are
informed by comments received from
state Title V MCH program leaders,
national MCH leaders, and other MCH
stakeholders.
Specific updates to this edition of the
Title V Maternal and Child Health
Services Block Grant to States Program:
Guidance and Forms for the Title V
Application/Annual Report include the
following:
(1) The performance measure
framework has been maintained, but a
state has added flexibility to determine
the best combination of National
Performance Measures (NPMs) and State
Performance Measures (SPMs) for
addressing its identified MCH priority
needs. States will address each priority
need by either a NPM or SPM.
(2) The required minimum number of
NPMs to be selected by a state has been
reduced from eight to five. States will
select at least one NPM in each of the
five population health domains,
specifically: (1) Women/Maternal
Health; (2) Perinatal/Infant Health; (3)
Child Health; (4) Children with Special
Health Care Needs (CSHCN); and (5)
Adolescent Health.
(3) A sixth and optional domain,
Cross-cutting and Systems Building, has
been added to replace the Cross-cutting/
Life Course domain. The three NPMs
that were formerly included in the
Cross-cutting/Life Course domain (i.e.,
NPM #13A/B, NPM #14 A/B and NPM
#15) have been incorporated into the
relevant population health domain(s).
No NPMs are included in the Crosscutting and Systems Building domain;
however, a state may choose to include
a SPM in this domain if relevant to its
priority needs.
(4) The focus on evidence-based or
evidence-informed strategies and
measures (ESMs) continues, with an
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enhanced definition of ‘‘evidence-base’’
provided. Clarifying instructions and
state examples of ESMs have been
added.
(5) Expectations around state Title V
reporting on family/consumer
partnership have been clarified. These
expectations include enhanced
discussion of specific program
activities, the impact they have on all
sectors of the MCH population, and
their demonstrated value in improving
MCH outcomes.
(6) The narrative reporting
requirements around services for
CSHCN have been strengthened to allow
each state to identify and define the
components of its system of services.
States are also encouraged to reflect on
the impact of these services within the
context of the identified priority needs
and the measures selected for the State
Action Plan.
(7) Further anticipated reductions to
state burden have been incorporated
through more streamlined narrative
reporting, particularly between the State
Overview, Needs Assessment, and State
Action Plan sections; clearer
descriptions of expected content in each
of the narrative sections; and refined
instructions for completing the data
reporting forms. Notable among these
updates is the restructuring of the State
Action Plan narrative discussion to
allow a Title V program greater
flexibility in describing its public health
framework (e.g., life course model),
leadership and partnership roles, crosscutting strategies, and the leveraging of
resources.
The full extent of the anticipated
burden reduction will be realized over
time as states become more familiar
with the updated instructions and
reporting requirements. The burden
estimates presented in the table below
are based on previous burden estimates
and consultation with a few states.
Need and Proposed Use of the
Information: Each year, states are
required to submit an application/
annual report for Federal funds for their
Title V MCH Services Block Grant to
States Program to HRSA’s MCHB
(Section 505(a) of Title V of the Social
Security Act). In addition, each state is
required to conduct a comprehensive
needs assessment every 5 years. The
information and instructions for the
preparation and submission of this
application/annual report are contained
in the Title V Maternal and Child
Health Services Block Grant to States
Program: Guidance and Forms for the
Title V Application/Annual Report.
Likely Respondents: Per section 505(a)
of Title V of the Social Security Act, the
MCH Block Grant application/annual
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Device type Product code Device name 21 CFR section
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
\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
------------------------------------------------------------------------
-------------------------------------------------------------------------
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.
------------------------------------------------------------------------
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
https://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