[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]


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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 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.
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    \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).
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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


