[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
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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