Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories, 14891-14893 [2022-05517]
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Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices
TABLE 1—FEE SCHEDULE FOR FY
2022
FY 2022
fee rates
Fee category
jspears on DSK121TN23PROD with NOTICES1
OMOR:
Tier 1 .......................................
Tier 2 .......................................
Facility Fees:
MDF ........................................
CMO ........................................
$507,021
101,404
24,178
16,119
VI. Fee Payment Options and
Procedures
The new fee rates are for the period
from October 1, 2021, through
September 30, 2022. To pay the OMOR,
MDF, and CMO fees, complete an OTC
Monograph User Fee Cover Sheet,
available at: https://userfees.fda.gov/
OA_HTML/omufaCAcdLogin.jsp. A user
fee identification (ID) number will be
generated. Payment must be made in
U.S. currency by electronic check or
wire transfer, payable to the order of the
Food and Drug Administration. The
preferred payment method is online
using electronic check (Automated
Clearing House (ACH) also known as
eCheck) or credit card for payments
under $25,000 (Discover, VISA,
MasterCard, American Express).
FDA has partnered with the U.S.
Department of the Treasury to use
Pay.gov, a web-based payment
application, for online electronic
payment. The Pay.gov feature is
available on the FDA website after
completing the OTC Monograph User
Fee Cover Sheet and generating the user
fee ID number. Secure electronic
payments can be submitted using the
User Fees Payment Portal at https://
userfees.fda.gov/pay (Note: Only full
payments are accepted. No partial
payments can be made online). Once an
invoice is located, ‘‘Pay Now’’ should be
selected to be redirected to Pay.gov.
Electronic payment options are based on
the balance due. Payment by credit card
is available for balances that are less
than $25,000. If the balance exceeds this
amount, only the ACH option is
available. Payments must be made using
U.S. bank accounts as well as U.S. credit
cards.
For payments made by wire transfer,
include the unique user fee ID number
to ensure that the payment is applied to
the correct fee(s). Without the unique
user fee ID number, the payment may
not be applied, which could result in
FDA not filing an OMOR request, for
example, and other penalties. The
originating financial institution may
charge a wire transfer fee. Applicable
wire transfer fees must be included with
payment to ensure fees are fully paid.
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Questions about wire transfer fees
should be addressed to the financial
institution. The account information for
wire transfers is as follows: U.S.
Department of the Treasury, TREAS
NYC, 33 Liberty St., New York, NY
10045, Acct. No.: 75060099, Routing
No.: 021030004, SWIFT: FRNYUS33. If
needed, FDA’s tax identification
number is 53–0196965.
If you are assessed an FY 2022
OMUFA facility fee and believe your
facility is not an OTC monograph drug
facility as described in this notice,
please contact CDERCollections@
fda.hhs.gov.
Dated: March 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05542 Filed 3–14–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–1593]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Accessories
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on medical device
accessory requests.
DATES: Submit either electronic or
written comments on the collection of
information by May 16, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 16, 2022.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 16, 2022. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
SUMMARY:
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14891
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2016–N–1593 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Device Accessories.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
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Federal Register / Vol. 87, No. 51 / Wednesday, March 16, 2022 / Notices
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 Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
VerDate Sep<11>2014
17:16 Mar 15, 2022
Jkt 256001
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Medical Device Accessories
OMB Control Number 0910–0823—
Extension
FDA’s guidance document entitled
‘‘Medical Device Accessories—
Describing Accessories and
Classification Pathways’’ (the
Accessories guidance) 1 is intended to
provide guidance to industry and FDA
staff about the regulation of accessories
to medical devices, to describe FDA’s
policy concerning the classification of
accessories, and to discuss the
application of this policy to devices that
are commonly used as accessories to
other medical devices. In addition, the
guidance explains what devices FDA
generally considers an ‘‘accessory’’ and
describes the processes under section
513(f)(6) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(f)(6)) to
allow requests for risk- and regulatory
control-based classification of
accessories.
The FDA Reauthorization Act of 2017
(FDARA) changed how FDA regulates
medical device accessories. Specifically,
section 707 of FDARA added section
513(f)(6) to the statute and requires that
FDA, upon request, classify existing and
new accessories notwithstanding the
classification of any other device with
which such accessory is intended to be
used. This means that the classification
1 The guidance document is available on FDA’s
website (https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/
medical-device-accessories-describing-accessoriesand-classification-pathways).
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of an accessory may not be the same as
its parent device, depending on the risks
of the accessory when used as intended
and the level of regulatory controls
necessary for reasonable assurance of
safety and effectiveness of the accessory.
Until an accessory is distinctly
classified, its existing classification will
continue to apply. This provision does
not preclude a manufacturer from
submitting a De Novo request for an
accessory.
Depending on an accessory’s
regulatory history, there are different
submission types, tracking mechanisms,
and deadlines:
(1) Existing accessory types are those
that have been identified in a
classification regulation or granted
marketing authorization as part of a
510(k), pre-market application (PMA),
or De Novo request (approved under
OMB control numbers 0910–0120,
0910–0231, and 0910–0844,
respectively). Manufacturers with
marketing authorization for an existing
accessory may request appropriate
classification through a new stand-alone
premarket submission (Existing
Accessory Request). Upon request, FDA
is required to meet with a manufacturer
or importer to discuss the appropriate
classification of an existing accessory
prior to submitting a written request.
Existing Accessory Requests will be
initially tracked as ‘‘Q-submissions’’
(approved under OMB control number
0910–0756). FDA has a statutory
deadline of 85 calendar days to respond
to an Existing Accessory Request.
(2) New accessory types are those that
have not been granted marketing
authorization as part of a 510(k), PMA,
or De Novo request. Manufacturers may
include new accessories into a 510(k) or
PMA with the parent device (New
Accessory Request). New Accessory
Requests will have the same deadline as
the 510(k) or PMA. Therefore, new
accessory types should follow the
applicable Medical Device User Fee
Amendments of 2017 deadline for the
parent submission. The decision for
New Accessory Requests will be
separate from the decision for the
marketing application.
For both Existing and New Accessory
Requests, manufacturers must request
proper classification of their accessory
in the submission and include draft
special controls, if requesting
classification into class II. The processes
that we use to classify an accessory will
be like those used for De Novo requests.
If FDA grants the Accessory Request,
FDA must issue an order establishing a
new classification regulation for the
accessory type. If FDA denies the
Accessory Request, FDA must issue a
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letter with a detailed description and
justification for our determination.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity; guidance for industry (GFI) section
Average
burden per
response
Total annual
responses
Total hours
Existing Accessory Request; GFI VI.A ................................
New Accessory Request ......................................................
10
5
1
1
10
5
40
40
400
200
Total ..............................................................................
........................
........................
........................
........................
600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on an evaluation of the
information collection, we have reduced
the estimated number of existing
requests from 15 to 10, and we have
reduced the estimated number of new
requests from 10 to 5. This adjustment
results in an overall reduction to the
information collection by 10 responses
and 400 hours annually. We believe
these adjustments more accurately
reflect the current number of requests
associated with medical device
accessory classifications.
Dated: March 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–05517 Filed 3–15–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0404]
Considerations for the Development of
Chimeric Antigen Receptor T Cell
Products; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Considerations for
the Development of Chimeric Antigen
Receptor T Cell Products; Draft
Guidance for Industry.’’ The draft
guidance document is intended to assist
sponsors, including industry and
academic sponsors, developing
Chimeric Antigen Receptor (CAR) T cell
products. The draft guidance includes
CAR T cell-specific recommendations
regarding chemistry, manufacturing,
and control (CMC), pharmacology and
toxicology, and clinical study design.
DATES: Submit either electronic or
written comments on the draft guidance
SUMMARY:
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Number of
responses per
respondent
VerDate Sep<11>2014
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by June 14, 2022 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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.’’
PO 00000
Frm 00074
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Instructions: All submissions received
must include the Docket No. FDA–
2021–D–0404 for ‘‘Considerations for
the Development of Chimeric Antigen
Receptor (CAR) T Cell Products; Draft
Guidance for Industry.’’ 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 Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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 Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
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]]>Agencies
[Federal Register Volume 87, Number 51 (Wednesday, March 16, 2022)]
[Notices]
[Pages 14891-14893]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05517]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-1593]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Accessories
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on medical device accessory
requests.
DATES: Submit either electronic or written comments on the collection
of information by May 16, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before May 16, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 16, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2016-N-1593 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Accessories.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential
[[Page 14892]]
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
Dockets Management Staff. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Medical Device Accessories
OMB Control Number 0910-0823--Extension
FDA's guidance document entitled ``Medical Device Accessories--
Describing Accessories and Classification Pathways'' (the Accessories
guidance) \1\ is intended to provide guidance to industry and FDA staff
about the regulation of accessories to medical devices, to describe
FDA's policy concerning the classification of accessories, and to
discuss the application of this policy to devices that are commonly
used as accessories to other medical devices. In addition, the guidance
explains what devices FDA generally considers an ``accessory'' and
describes the processes under section 513(f)(6) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(f)(6)) to allow requests for
risk- and regulatory control-based classification of accessories.
---------------------------------------------------------------------------
\1\ The guidance document is available on FDA's website (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways).
---------------------------------------------------------------------------
The FDA Reauthorization Act of 2017 (FDARA) changed how FDA
regulates medical device accessories. Specifically, section 707 of
FDARA added section 513(f)(6) to the statute and requires that FDA,
upon request, classify existing and new accessories notwithstanding the
classification of any other device with which such accessory is
intended to be used. This means that the classification of an accessory
may not be the same as its parent device, depending on the risks of the
accessory when used as intended and the level of regulatory controls
necessary for reasonable assurance of safety and effectiveness of the
accessory. Until an accessory is distinctly classified, its existing
classification will continue to apply. This provision does not preclude
a manufacturer from submitting a De Novo request for an accessory.
Depending on an accessory's regulatory history, there are different
submission types, tracking mechanisms, and deadlines:
(1) Existing accessory types are those that have been identified in
a classification regulation or granted marketing authorization as part
of a 510(k), pre-market application (PMA), or De Novo request (approved
under OMB control numbers 0910-0120, 0910-0231, and 0910-0844,
respectively). Manufacturers with marketing authorization for an
existing accessory may request appropriate classification through a new
stand-alone premarket submission (Existing Accessory Request). Upon
request, FDA is required to meet with a manufacturer or importer to
discuss the appropriate classification of an existing accessory prior
to submitting a written request. Existing Accessory Requests will be
initially tracked as ``Q-submissions'' (approved under OMB control
number 0910-0756). FDA has a statutory deadline of 85 calendar days to
respond to an Existing Accessory Request.
(2) New accessory types are those that have not been granted
marketing authorization as part of a 510(k), PMA, or De Novo request.
Manufacturers may include new accessories into a 510(k) or PMA with the
parent device (New Accessory Request). New Accessory Requests will have
the same deadline as the 510(k) or PMA. Therefore, new accessory types
should follow the applicable Medical Device User Fee Amendments of 2017
deadline for the parent submission. The decision for New Accessory
Requests will be separate from the decision for the marketing
application.
For both Existing and New Accessory Requests, manufacturers must
request proper classification of their accessory in the submission and
include draft special controls, if requesting classification into class
II. The processes that we use to classify an accessory will be like
those used for De Novo requests. If FDA grants the Accessory Request,
FDA must issue an order establishing a new classification regulation
for the accessory type. If FDA denies the Accessory Request, FDA must
issue a
[[Page 14893]]
letter with a detailed description and justification for our
determination.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Activity; guidance for industry Number of responses per Total annual burden per Total hours
(GFI) section respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Existing Accessory Request; GFI 10 1 10 40 400
VI.A...........................
New Accessory Request........... 5 1 5 40 200
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 600
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Based on an evaluation of the information collection, we have
reduced the estimated number of existing requests from 15 to 10, and we
have reduced the estimated number of new requests from 10 to 5. This
adjustment results in an overall reduction to the information
collection by 10 responses and 400 hours annually. We believe these
adjustments more accurately reflect the current number of requests
associated with medical device accessory classifications.
Dated: March 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05517 Filed 3-15-22; 8:45 am]
BILLING CODE 4164-01-P
