[Federal Register Volume 89, Number 52 (Friday, March 15, 2024)]
[Notices]
[Pages 18947-18948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05580]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1774]
Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program; Draft Guidance for Industry and
Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Requests for Feedback
and Meetings for Medical Device Submissions: The Q-Submission
Program.'' This draft guidance document provides an overview of the
mechanisms available to submitters through which they can request
interactions with FDA related to medical device submissions. This draft
guidance, when finalized, is intended to supersede the document
entitled ``Requests for Feedback and Meetings for Medical Device
Submissions: The Q-Submission Program'' issued on June 2, 2023, and
provides clarification and additional information on the scope of Q-
Submission (Q-Sub) types, better delineation of how to obtain feedback
for different types of questions (i.e., informal communication vs. Pre-
Submission or other Q-Submission types), and improved examples. This
draft guidance is not final nor is it for implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by May 14, 2024 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
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'').
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-2018-D-1774 for ``Requests for Feedback and Meetings for Medical
Device Submissions: The Q-Submission Program.'' Received comments 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.
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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program'' to the Office of Policy, Center for Devices
and Radiological Health, Food and Drug Administration, 10903
[[Page 18948]]
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2438, Silver Spring, MD 20993-0002, 301-796-5640 or
James Myers, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
As part of the Medical Device User Fee Amendments of 2022, the
Agency committed to issuing a draft guidance to provide additional
information to assist in identifying the circumstances in which an
applicant's question is most appropriate for informal communication
instead of a Pre-Submission and to provide an opportunity for the
public to comment on the updated guidance. This draft guidance reflects
such additional information and further clarifies other elements of the
Q-Sub Program.
This draft guidance provides an overview of the mechanisms
available to submitters through which they can request interactions
with FDA, including written feedback and/or a meeting regarding medical
device Investigational Device Exemption applications, Premarket
Approval applications, Humanitarian Device Exemption applications, De
Novo requests, 510(k) submissions, Clinical Laboratory Improvement
Amendments (CLIA) Waiver by Applications, Dual 510(k) and CLIA Waiver
by Application submissions, Accessory Classification Requests, and
certain Investigational New Drug applications and Biologics License
Applications submitted to the Center for Biologics Evaluation and
Research.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Requests for
Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
II. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00001677 and complete title to
identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
------------------------------------------------------------------------
OMB control
21 CFR part or guidance Topic No.
------------------------------------------------------------------------
807, subpart E................. Premarket notification. 0910-0120
814, subparts A through E...... Premarket approval..... 0910-0231
814, subpart H................. Humanitarian Use 0910-0332
Devices; Humanitarian
Device Exemption.
812............................ Investigational Device 0910-0078
Exemption.
860, subpart D................. De Novo classification 0910-0844
process.
``Requests for Feedback and Q-submissions and Early 0910-0756
Meetings for Medical Device Payor Feedback Request
Submissions: The Q-Submission Programs for Medical
Program''. Devices.
``Administrative Procedures for CLIA Administrative 0910-0607
CLIA Categorization'' and Procedures; CLIA
``Recommendations: Clinical Waivers.
Laboratory Improvement
Amendments of 1988 (CLIA)
Waiver Applications for
Manufacturers of In Vitro
Diagnostic Devices''.
``Medical Device Accessories-- Accessories............ 0910-0823
Describing Accessories and
Classification Pathways''.
Form FDA 3601 ``Medical Device Medical Device User Fee 0910-0511
User Fee Cover Sheet''; Form Cover Sheet and Device
FDA 3601(a), the ``Device Facility User Fee
Facility User Fee Cover Cover Sheet--Form FDA
Sheet;'' ``FDA and Industry 3601 and Form 3601(a);
Procedures for Section 513(g) 513(g) Request for
Requests for Information under Information.
the Federal Food, Drug, and
Cosmetic Act''.
``Center for Devices and Appeals Process........ 0910-0738
Radiological Health Appeals
Processes''.
``Emergency Use Authorization Emergency Use 0910-0595
of Medical Products and Authorization.
Related Authorities''.
312............................ Investigational New 0910-0014
Drug Application.
601............................ Biologics License 0910-0338
Application.
------------------------------------------------------------------------
Dated: March 12, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05580 Filed 3-14-24; 8:45 am]
BILLING CODE 4164-01-P