[Federal Register Volume 89, Number 198 (Friday, October 11, 2024)]
[Notices]
[Pages 82612-82614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23544]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1021]


Notice to Public of Website Location of Center for Devices and 
Radiological Health Fiscal Year 2025 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the website location where the Agency will post two lists of 
guidance documents that the Center for Devices and Radiological Health 
(CDRH) intends to publish in fiscal year (FY) 2025. In addition, FDA 
has established a docket where interested parties may comment on the 
priority of topics for guidance, provide comments and/or propose draft 
language for those topics, suggest topics for new or different guidance 
documents, comment on the applicability of guidance documents that have 
issued previously, and provide any other comments that could benefit 
the CDRH guidance program and its engagement with interested parties. 
This feedback is critical to the CDRH guidance program to ensure that 
we meet the needs of interested parties.

DATES: Either electronic or written comments on the notice must be 
submitted by December 10, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 10, 2024. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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

[[Page 82613]]

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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2012-N-1021 for ``Notice to Public of website Location of CDRH 
Fiscal Year 2025 Proposed Guidance Development.'' 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.
    <bullet> 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.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: Erica Takai, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations on the Medical Device User Fee Amendments of 
2012, title II, Food and Drug Administration Safety and Innovation Act 
(Pub. L. 112-144), FDA agreed to meet a variety of quantitative and 
qualitative goals intended to help get safe and effective medical 
devices to market more quickly. Among these commitments included:
    <bullet> Annually posting a list of priority medical device 
guidance documents that the Agency intends to publish within 12 months 
of the date this list is published each fiscal year (the ``A-list''), 
and
    <bullet> Annually posting a list of device guidance documents that 
the Agency intends to publish, as the Agency's guidance-development 
resources permit each fiscal year (the ``B-list'').
    The Medical Device User Fee Amendments of 2017 (MDUFA IV), Title 
II, FDA Reauthorization Act of 2017 (Pub. L. 115-52), maintained these 
commitments.
    In addition, to ensure that final guidance documents continue to 
provide interested parties with the Agency's current thinking, CDRH 
annually conducts a staged review of previously issued final guidances 
in collaboration with interested parties. CDRH intends to annually 
provide lists of previously issued final guidances that are subject to 
review in 10-year increments to facilitate a continuous and systematic 
assessment of the applicability of existing guidances. For instance, in 
FY 2025, CDRH is providing a list of the final guidance documents that 
issued in 2015, 2005, 1995, and 1985; in FY 2026 we expect to provide a 
list of the final guidance documents that issued in 2016, 2006, 1996, 
and 1986, and so on. Consistent with the Good Guidance Practices 
regulation at 21 CFR 10.115(f)(4), CDRH would appreciate suggestions 
that CDRH revise or withdraw an already existing guidance document. We 
request that the suggestion clearly explain why the guidance document 
should be revised or withdrawn and, if applicable, how it should be 
revised. While we are requesting feedback on the list of previously 
issued final guidances located in the annual agenda website, feedback 
on any guidance is appreciated and will be considered.
    FDA welcomes comments on any or all of the guidance documents on 
the lists as explained in 21 CFR 10.115(f)(5). FDA has established 
Docket No. FDA-2012-N-1021 where comments on the FY 2025 lists, draft 
language for guidance documents on those topics, suggestions for new or 
different guidances, and relative priority of guidance documents may be 
submitted and shared with the public (see ADDRESSES). FDA believes this 
docket is a valuable tool for receiving information from interested 
parties. FDA anticipates that feedback from interested parties will 
allow CDRH to better prioritize and more efficiently draft guidances to 
meet the needs of the Agency and interested parties.
    In addition to posting the lists of prioritized device guidance 
documents, CDRH has identified as a priority, and has devoted resources 
to, finalization of draft guidance documents. To ensure the timely 
completion or reissuance of draft guidances, in FY 2015 CDRH committed 
to performance goals for current and future draft guidance documents. 
For draft guidance documents issued after October 1, 2014, CDRH 
committed to finalize, withdraw, reopen the comment period, or issue 
new draft guidance on the topic for 80 percent of the documents within 
3 years of the close of the comment period and for the remaining 20 
percent, within 5 years. As part of MDUFA IV commitments, FDA 
reaffirmed this commitment, as resources permit.

[[Page 82614]]

    Fulfillment of these commitments will be reflected through the 
issuance of updated guidance on existing topics, withdrawal of 
guidances that no longer reflect FDA's current thinking on a particular 
topic, and annual updates to the A-list and B-list announced in this 
notice.

II. Website Location of Guidance Lists

    This notice announces the website location of the document that 
provides the A- and B-lists of guidance documents, which CDRH is 
intending to publish during FY 2025. To access these two lists, visit 
FDA's website at https:/www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development. We note that the topics on these lists may be removed or 
modified based on current priorities, as well as comments received 
regarding these lists. Furthermore, FDA and CDRH priorities are subject 
to change at any time (e.g., newly identified safety issues). The 
Agency is not required to publish every guidance on either list if the 
resources needed would be to the detriment of meeting quantitative 
review timelines and statutory obligations. In addition, the Agency is 
not precluded from issuing guidance documents that are not on either 
list.

    Dated: October 7, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-23544 Filed 10-10-24; 8:45 am]
BILLING CODE 4164-01-P