Notice2022-05517
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Accessories
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 51 (Wednesday, March 16, 2022)</title>
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[Federal Register Volume 87, Number 51 (Wednesday, March 16, 2022)]
[Notices]
[Pages 14891-14893]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-05517]
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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.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#dc8c8e9d8fa8bdbaba9cbab8bdf2b4b4aff2bbb3aa"><span class="__cf_email__" data-cfemail="17474556446376717157717376397f7f6439707861">[email protected]</span></a>.
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.
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\1\ The guidance document is available on FDA's website (<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-accessories-describing-accessories-and-classification-pathways</a>).
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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
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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\
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Number of Average
Activity; guidance for industry Number of responses per Total annual burden per Total hours
(GFI) section respondents respondent responses response
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Existing Accessory Request; GFI 10 1 10 40 400
VI.A...........................
New Accessory Request........... 5 1 5 40 200
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Total....................... .............. .............. .............. .............. 600
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\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
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