[Federal Register Volume 84, Number 65 (Thursday, April 4, 2019)]
[Notices]
[Pages 13296-13298]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06551]


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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 or Agency) 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 information collections regarding medical 
device accessories requests.

DATES: Submit either electronic or written comments on the collection 
of information by June 3, 2019.

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 June 3, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 3, 2019. 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'').

[[Page 13297]]

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 ``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.
     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.gpo.gov/fdsys/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.

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. 3501-3520), 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 ``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 (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

[[Page 13298]]

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.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                               Number of
                                                  Number of    responses      Total       Average
                    Activity                     respondents      per         annual     burden per  Total hours
                                                               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: March 29, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06551 Filed 4-3-19; 8:45 am]
 BILLING CODE 4164-01-P