Document ID: FDA-2016-N-1593-0007
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Accessories
Posted Date: 2022-08-12T04:00Z

[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49850-49851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17296]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1593]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Medical Device 
Accessories

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by September 12, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0823. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device Accessories

OMB Control Number 0910-0823--Extension

    FDA's guidance document entitled ``Medical Device Accessories--
Describing Accessories and Classification Pathways'' \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) (Pub. L. 115-52) 
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), premarket approval 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,

[[Page 49851]]

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 letter with a detailed description and justification for our 
determination.
    In the Federal Register of March 16, 2022 (87 FR 14891), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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: August 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17296 Filed 8-11-22; 8:45 am]
BILLING CODE 4164-01-P