Medical Device Accessories-Describing Accessories and Classification Pathway for New Accessory Types; Guidance for Industry and Food and Drug Administration Staff; Availability, 96467-96469 [2016-31669]
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Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
21 CFR section/Form No.
Average
burden per
response
Total annual
responses
Total hours
101.108; written proposal for requesting temporary exemptions from certain regulations for the purpose of conducting food labeling experiments ...................................
1
1
1
40
40
Total ..............................................................................
........................
........................
........................
........................
80,915
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated annual third party
disclosure, recordkeeping, and reporting
burdens are based on our
communications with industry and our
knowledge of and experience with food
labeling and the submission of petitions
and requests to us.
We expect that the burden hours for
submissions under § 101.108 will be
insignificant. Section 101.108 was
originally issued to provide a procedure
whereby we could grant exemptions
from certain food labeling requirements.
Exemption petitions have infrequently
been submitted in the recent past; none
have been submitted since publication
on January 6, 1993, of the final
regulations implementing section 403(q)
and (r) of the FD&C Act. Thus, in order
to maintain OMB approval of § 101.108
to accommodate the possibility that a
food producer may propose to conduct
a labeling experiment on its own
initiative, we estimate that we will
receive one or fewer submissions under
§ 101.108 in the next 3 years.
Dated: December 27, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31733 Filed 12–29–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–0025]
Medical Device Accessories—
Describing Accessories and
Classification Pathway for New
Accessory Types; Guidance for
Industry and Food and Drug
Administration Staff; Availability
srobinson on DSK5SPTVN1PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Medical Device Accessories—
Describing Accessories and
SUMMARY:
VerDate Sep<11>2014
19:18 Dec 29, 2016
Jkt 241001
Classification Pathways for New
Accessory Types.’’ This document
provides guidance to industry and FDA
staff about the regulation of accessories
to medical devices. The guidance
explains what devices FDA generally
considers an ‘‘accessory’’ and
encourages use of the de novo
classification process under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) to allow manufacturers and
other parties to request risk- and
regulatory control-based classification of
accessories of a new type (i.e.,
accessories of a type that has not been
previously classified under the FD&C
Act, cleared for marketing under a
510(k) submission, or approved in an
application for premarket approval
(PMA)).
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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 https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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–
2015–D–0025 for ‘‘Medical Device
Accessories—Describing Accessories
and Classification Pathway for New
Accessory Types.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• 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
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
E:\FR\FM\30DEN1.SGM
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96468
Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices
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: https://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 https://
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 the guidance
document is available for download
from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Medical Device
Accessories—Describing Accessories
and Classification Pathway for New
Accessory Types’’ to the Office of the
Center Director, Guidance and Policy
Development, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Erica Takai, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring,
MD 20993–0002, 301–796–6353 or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave,. Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
srobinson on DSK5SPTVN1PROD with NOTICES
I. Background
FDA has jurisdiction over accessories
because the definition of the term
‘‘device’’ provided in section 201(h) of
the FD&C Act defines ‘‘device’’ to
include, among other things, an
‘‘accessory.’’ All accessories to articles
that meet this definition of ‘‘device’’ are
regulated under the FD&C Act.
VerDate Sep<11>2014
19:18 Dec 29, 2016
Jkt 241001
This guidance is intended to provide
guidance to industry and FDA staff
about the regulation of accessories to
medical devices. Accordingly, this
guidance describes the types of devices
that FDA generally considers as
accessories and discusses the risk- and
regulatory control-based classification
paradigm for these accessories. This
information is expected to provide a
greater level of transparency with
regards to the classification of
accessories and will aid FDA staff and
industry in assuring that these devices
are subject to an appropriate level of
regulatory oversight by FDA. In
addition, this guidance describes the
use of the de novo classification process
under section 513(f)(2) of the FD&C Act
(21 U.S.C. 360c(f)(2)) for manufacturers
to request risk- and regulatory controlbased classifications of accessories of a
new type that are low-moderate risk for
which general controls or general and
special controls provide a reasonable
assurance of safety and effectiveness,
but for which there is no legally
marketed predicate device.
For the purposes of this guidance
document, an ‘‘accessory’’ is defined as
‘‘a finished device that is intended to
support, supplement, and/or augment
the performance of one or more parent
devices.’’ It is important to note that
FDA does not generally consider articles
that do not meet the definition of an
accessory as accessories simply because
they may be used in conjunction with
a device.
This guidance clarifies that
classification of accessory devices, as for
non-accessory devices, should reflect
the risks of the device when used as
intended and the level of regulatory
controls necessary to provide a
reasonable assurance of safety and
effectiveness. Classifying an accessory
in the same class as its parent device is
appropriate when the accessory, when
used as intended with the parent device,
meets the criteria for placement in the
class of the parent device. However,
some accessories can have a lower risk
profile than that of their parent device
and, therefore, may warrant being
regulated in a lower class.
In the Federal Register of January 20,
2015 (80 FR 2710), FDA published a
notice of availability for the draft
guidance entitled ‘‘Medical Device
Accessories: Defining Accessories and
Classification Pathway for New
Accessory Types.’’ FDA revised the
guidance as appropriate in response to
the comments. We received comments
requesting that the scope of the
guidance be expanded to apply to
existing accessories that were
previously classified. FDA is continuing
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
to explore mechanisms for risk- and
regulatory control-based reclassification
of existing accessories. Therefore, the
scope of the guidance has not been
expanded and includes the use of the de
novo classification process to classify
accessories of a new type.
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on the regulation of
medical device accessories. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the Internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Medical Device Accessories:
Describing Accessories and
Classification Pathway for New
Accessory Types’’ may send an email
request to CDRH-Guidance@fda.hhs.gov
to receive an electronic copy of the
document. Please use the document
number 1770 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
The guidance also refers to previously
approved collections of information
found in FDA regulations. The
collections of information in 21 CFR
parts 801 and 809 have been approved
under OMB control number 0910–0485;
the collections of information in 21 CFR
part 807, subpart E have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 814 have been approved under
OMB control number 0910–0231; the
collections of information in 21 CFR
part 860, subpart C have been approved
under OMB control number 0910–0138;
and the collection of information for
new medical device accessories devices
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Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Notices
have been approved under OMB control
number 0910–0823.
DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[Docket No. FR–5907–N–53]
Federal Property Suitable as Facilities
To Assist the Homeless
[FR Doc. 2016–31669 Filed 12–29–16; 8:45 am]
Office of the Assistant
Secretary for Community Planning and
Development, HUD.
ACTION: Notice.
AGENCY:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health Statement
of Organization, Functions, and
Delegations of Authority
Part N, National Institutes of Health
(NIH), of the Statement of Organization,
Functions, and Delegations of Authority
for the Department of Health and
Human Services (40 FR 22859, May 27,
1975, as amended most recently at 77
FR 1941, January 12, 2012, and
redesignated from Part HN as Part N at
60 FR 56605, November 9, 1995), is
amended as set forth below to establish
the All of UsSM Research Program
Office.
Section N–A, Organization and
Functions, is amended as follows:
Immediately after the paragraph headed
‘‘Office of the Director’’(OD), insert the
following:
All Of Us Research Program Office
srobinson on DSK5SPTVN1PROD with NOTICES
(HNAK) (1) Oversees the design,
development, implementation, and
evaluation of the All of Us Resesarch
Program, creating the largest and most
diverse research cohort of its kind, to
foster a new era of medicine in which
researchers, providers and patients work
together to develop individualized care
by supporting research into the complex
factors promoting health and treatments
to cure disease.
Delegations of Authority Statement:
All delegations and redelegations of
authority to officers and employees of
the NIH that were in effect immediately
prior to the effective date of this
reorganization and are consistent with
this reorganization shall continue in
effect, pending further redelegation.
Dated: December 23, 2016.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2016–31687 Filed 12–29–16; 8:45 am]
BILLING CODE 4140–01–P
VerDate Sep<11>2014
19:18 Dec 29, 2016
Jkt 241001
This Notice identifies
unutilized, underutilized, excess, and
surplus Federal property reviewed by
HUD for suitability for use to assist the
homeless.
FOR FURTHER INFORMATION CONTACT:
Juanita Perry, Department of Housing
and Urban Development, 451 Seventh
Street SW., Room 7266, Washington, DC
20410; telephone (202) 402–3970; TTY
number for the hearing- and speechimpaired (202) 708–2565 (these
telephone numbers are not toll-free),
call the toll-free Title V information line
at 800–927–7588 or send an email to
title5@hud.gov .
SUPPLEMENTARY INFORMATION: In
accordance with 24 CFR part 581 and
section 501 of the Stewart B. McKinney
Homeless Assistance Act (42 U.S.C.
11411), as amended, HUD is publishing
this Notice to identify Federal buildings
and other real property that HUD has
reviewed for suitability for use to assist
the homeless. The properties were
reviewed using information provided to
HUD by Federal landholding agencies
regarding unutilized and underutilized
buildings and real property controlled
by such agencies or by GSA regarding
its inventory of excess or surplus
Federal property. This Notice is also
published in order to comply with the
December 12, 1988 Court Order in
National Coalition for the Homeless v.
Veterans Administration, No. 88–2503–
OG (D.D.C.).
Properties reviewed are listed in this
Notice according to the following
categories: Suitable/available, suitable/
unavailable, and suitable/to be excess,
and unsuitable. The properties listed in
the three suitable categories have been
reviewed by the landholding agencies,
and each agency has transmitted to
HUD: (1) Its intention to make the
property available for use to assist the
homeless, (2) its intention to declare the
property excess to the agency’s needs, or
(3) a statement of the reasons that the
property cannot be declared excess or
made available for use as facilities to
assist the homeless.
Properties listed as suitable/available
will be available exclusively for
homeless use for a period of 60 days
SUMMARY:
National Institutes of Health
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
96469
from the date of this Notice. Where
property is described as for ‘‘off-site use
only’’ recipients of the property will be
required to relocate the building to their
own site at their own expense.
Homeless assistance providers
interested in any such property should
send a written expression of interest to
HHS, addressed to: Ms. Theresa M.
Ritta, Chief Real Property Branch, the
Department of Health and Human
Services, Room 12–07, Parklawn
Building, 5600 Fishers Lane, Rockville,
MD 20857, (301)-443–2265 (This is not
a toll-free number.) HHS will mail to the
interested provider an application
packet, which will include instructions
for completing the application. In order
to maximize the opportunity to utilize a
suitable property, providers should
submit their written expressions of
interest as soon as possible. For
complete details concerning the
processing of applications, the reader is
encouraged to refer to the interim rule
governing this program, 24 CFR part
581.
For properties listed as suitable/to be
excess, that property may, if
subsequently accepted as excess by
GSA, be made available for use by the
homeless in accordance with applicable
law, subject to screening for other
Federal use. At the appropriate time,
HUD will publish the property in a
Notice showing it as either suitable/
available or suitable/unavailable.
For properties listed as suitable/
unavailable, the landholding agency has
decided that the property cannot be
declared excess or made available for
use to assist the homeless, and the
property will not be available.
Properties listed as unsuitable will
not be made available for any other
purpose for 20 days from the date of this
Notice. Homeless assistance providers
interested in a review by HUD of the
determination of unsuitability should
call the toll free information line at 1–
800–927–7588 or send an email to
title5@hud.gov for detailed instructions,
or write a letter to Ann Marie Oliva at
the address listed at the beginning of
this Notice. Included in the request for
review should be the property address
(including zip code), the date of
publication in the Federal Register, the
landholding agency, and the property
number.
For more information regarding
particular properties identified in this
Notice (e.g., acreage, floor plan,
condition of property, existing sanitary
facilities, exact street address),
providers should contact the
appropriate landholding agencies at the
following address(es): AGRICULTURE:
Ms. Debra Kerr, Department of
E:\FR\FM\30DEN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Notices]
[Pages 96467-96469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31669]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-D-0025]
Medical Device Accessories--Describing Accessories and
Classification Pathway for New Accessory Types; Guidance for Industry
and Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Medical Device Accessories--
Describing Accessories and Classification Pathways for New Accessory
Types.'' This document provides guidance to industry and FDA staff
about the regulation of accessories to medical devices. The guidance
explains what devices FDA generally considers an ``accessory'' and
encourages use of the de novo classification process under the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) to allow manufacturers and
other parties to request risk- and regulatory control-based
classification of accessories of a new type (i.e., accessories of a
type that has not been previously classified under the FD&C Act,
cleared for marketing under a 510(k) submission, or approved in an
application for premarket approval (PMA)).
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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-2015-D-0025 for ``Medical Device Accessories--Describing
Accessories and Classification Pathway for New Accessory Types.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
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 https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be
[[Page 96468]]
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: https://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 https://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 the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Medical Device Accessories--Describing Accessories and Classification
Pathway for New Accessory Types'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353 or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave,. Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has jurisdiction over accessories because the definition of the
term ``device'' provided in section 201(h) of the FD&C Act defines
``device'' to include, among other things, an ``accessory.'' All
accessories to articles that meet this definition of ``device'' are
regulated under the FD&C Act.
This guidance is intended to provide guidance to industry and FDA
staff about the regulation of accessories to medical devices.
Accordingly, this guidance describes the types of devices that FDA
generally considers as accessories and discusses the risk- and
regulatory control-based classification paradigm for these accessories.
This information is expected to provide a greater level of transparency
with regards to the classification of accessories and will aid FDA
staff and industry in assuring that these devices are subject to an
appropriate level of regulatory oversight by FDA. In addition, this
guidance describes the use of the de novo classification process under
section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)) for
manufacturers to request risk- and regulatory control-based
classifications of accessories of a new type that are low-moderate risk
for which general controls or general and special controls provide a
reasonable assurance of safety and effectiveness, but for which there
is no legally marketed predicate device.
For the purposes of this guidance document, an ``accessory'' is
defined as ``a finished device that is intended to support, supplement,
and/or augment the performance of one or more parent devices.'' It is
important to note that FDA does not generally consider articles that do
not meet the definition of an accessory as accessories simply because
they may be used in conjunction with a device.
This guidance clarifies that classification of accessory devices,
as for non-accessory devices, should reflect the risks of the device
when used as intended and the level of regulatory controls necessary to
provide a reasonable assurance of safety and effectiveness. Classifying
an accessory in the same class as its parent device is appropriate when
the accessory, when used as intended with the parent device, meets the
criteria for placement in the class of the parent device. However, some
accessories can have a lower risk profile than that of their parent
device and, therefore, may warrant being regulated in a lower class.
In the Federal Register of January 20, 2015 (80 FR 2710), FDA
published a notice of availability for the draft guidance entitled
``Medical Device Accessories: Defining Accessories and Classification
Pathway for New Accessory Types.'' FDA revised the guidance as
appropriate in response to the comments. We received comments
requesting that the scope of the guidance be expanded to apply to
existing accessories that were previously classified. FDA is continuing
to explore mechanisms for risk- and regulatory control-based
reclassification of existing accessories. Therefore, the scope of the
guidance has not been expanded and includes the use of the de novo
classification process to classify accessories of a new type.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on the regulation of medical device
accessories. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. Persons
unable to download an electronic copy of ``Medical Device Accessories:
Describing Accessories and Classification Pathway for New Accessory
Types'' may send an email request to CDRH-Guidance@fda.hhs.gov to
receive an electronic copy of the document. Please use the document
number 1770 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520),
Federal Agencies must obtain approval from the Office of Management and
Budget (OMB) for each collection of information they conduct or
sponsor. The guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR parts 801 and 809 have been approved under OMB control number
0910-0485; the collections of information in 21 CFR part 807, subpart E
have been approved under OMB control number 0910-0120; the collections
of information in 21 CFR part 814 have been approved under OMB control
number 0910-0231; the collections of information in 21 CFR part 860,
subpart C have been approved under OMB control number 0910-0138; and
the collection of information for new medical device accessories
devices
[[Page 96469]]
have been approved under OMB control number 0910-0823.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31669 Filed 12-29-16; 8:45 am]
BILLING CODE 4164-01-P
