Document ID: FDA-2016-N-1593-0004
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: 2019-08-13T04:00Z

[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40067-40068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17346]

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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) 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: Fax written comments on the collection of information by 
September 12, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 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, 
PRAStaff@fda.hhs.gov.

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 ``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

[[Page 40068]]

generally considers an ``accessory'' and describes the processes under 
section 513(f)(6) of the Federal Food, Drug, and Cosmetic Act (FD&C 
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/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm429672.pdf).
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    We are requesting OMB approval to revise this information 
collection request (ICR) by adding burden estimates for two new 
accessory classification pathways created by the FDA Reauthorization 
Act of 2017 (FDARA) (Pub. L. 115-52).
    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.
    When the Accessories guidance originally issued, FDA encouraged the 
use of the De Novo classification process to allow manufacturers to 
request risk- and regulatory control-based classification of 
accessories of a new type. FDA's recommendations in the guidance 
represented a new information collection as an accessory classification 
De Novo request. The information collected for an accessory 
classification De Novo request is substantially the same as a De Novo 
request (since approved under OMB control number 0910-0844), is 
submitted in the same manner, and has the same estimated information 
collection burden. The burden estimate associated with ``De Novo 
request under 21 U.S.C. 513(f)(2)(i)'' and ``De Novo request under 21 
U.S.C. 513(f)(2)(ii),'' in OMB control number 0910-0844, includes De 
Novo requests for accessories. We have determined that the burden 
estimate for ``Accessory Classification De Novo Requests'' in this ICR 
(Accessory Classification Requests; OMB control number 0910-0823) is 
redundant and have, therefore, removed it.
    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 letter with a detailed description and justification for our 
determination.
    In the Federal Register of April 4, 2019 (84 FR 13296), 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                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Existing Accessory Request......              15               1              15              40             600
New Accessory Request...........              10               1              10              40             400
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    Total.......................  ..............  ..............  ..............  ..............           1,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We expect to receive approximately 15 Existing Accessory Requests 
and 10 New Accessory Requests per year. Based on estimates by FDA 
administrative and technical staff who are familiar with the submission 
process for accessory classification requests, we estimate that the 
``Average Burden per Response'' for both Existing and New Accessory 
Requests will be approximately 40 hours per submission.
    Our estimated burden for the information collection reflects an 
overall decrease of 440 hours and an increase of 17 responses. Factors 
contributing to the revision of the burden estimate include the 
addition of the two new accessory classification pathways created by 
FDARA and the removal of redundant burden described earlier in this 
document.

    Dated: August 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17346 Filed 8-12-19; 8:45 am]
BILLING CODE 4164-01-P