[Federal Register Volume 84, Number 88 (Tuesday, May 7, 2019)]
[Notices]
[Pages 19923-19925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09338]
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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; Guidance for Industry and Food
and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Requests for Feedback
and Meetings for Medical Device Submissions: The Q-Submission
Program.'' This guidance document provides an overview of the
mechanisms available to applicants through which they can request
feedback from or a meeting with FDA regarding potential or planned
medical device investigational device exemption (IDE) applications,
premarket approval applications (PMAs), humanitarian device exemption
(HDE) applications, evaluation of automatic class III designations (De
Novo requests), premarket notification (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 (IND)
applications and biologics license applications (BLAs).
DATES: The announcement of the guidance is published in the Federal
Register on May 7, 2019.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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
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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.
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.
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 guidance document entitled
``Requests for Feedback and Meetings for Medical Device Submissions:
The Q-Submission Program'' to the Office of Policy, Guidance and Policy
Development, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or to the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
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. 1650, Silver Spring, MD 20993-0002, 301-796-6524;
or Stephen Ripley, 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
The pre-IDE program was established in 1995 to provide applicants a
mechanism to obtain FDA feedback on future IDE applications prior to
their submission. Over time, the pre-IDE program evolved to include
feedback on PMA applications, HDE applications, De Novo requests, and
510(k) submissions, as well as to address whether a clinical study
requires submission of an IDE.
To capture this evolution, the Secretary of Health and Human
Services' 2012 Commitment Letter to Congress regarding the Medical
Device User Fee Amendments of 2012 (MDUFA III) included FDA's
commitment to institute a structured process for managing these
interactions, referring to them as ``Pre-Submissions.'' The Pre-
Submission Guidance, published February 18, 2014, implemented the
broader Q-Submission (Q-Sub) Program, which includes Pre-Submissions
(Pre-Subs), as well as additional opportunities to engage with FDA.
As part of the Medical Device User Fee Amendments of 2017 (MDUFA
IV), industry and the Agency agreed to refine the Q-Sub Program with
changes related to the scheduling of Pre-Sub meetings and a new
performance goal on the timing of FDA feedback on Pre-Subs. This
guidance reflects those changes and clarifies other elements of the Q-
Sub program.
This guidance document provides an overview of the mechanisms
available to submitters through which they can request feedback from or
a meeting with FDA regarding potential or planned medical device IDE
applications, PMAs, HDE applications, De Novo requests, 510(k)
Submissions, CLIA Waiver by Application, Dual 510(k) and CLIA Waiver by
Application Submissions, Accessory Classification Requests, and certain
INDs and BLAs submitted to the Center for Biologics Evaluation and
Research. FDA considered comments received on the draft guidance, which
was announced in the Federal Register of June 7, 2018 (83 FR 26482).
FDA revised the guidance as appropriate in response to the comments.
This guidance supersedes the document entitled ``Requests for Feedback
on Medical Device Submissions: The Pre-Submission Program and Meetings
with Food and Drug Administration Staff,'' issued on September 29,
2017.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
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practices regulation (21 CFR 10.115). The guidance represents 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. This guidance
is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. 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 1677 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:
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OMB control
21 CFR Part or guidance Topic No.
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``Requests for Feedback on Q-submissions......... 0910-0756
Medical Device Submissions: The
Pre-Submission Program and
Meetings with Food and Drug
Administration Staff''.
``De Novo Classification Process De Novo Requests...... 0910-0844
(Evaluation of Automatic Class
III Designation)''.
``Recommendations: Clinical CLIA Waivers.......... 0910-0598
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''.
312............................. Investigational New 0910-0014
Drug Application.
601............................. Biologics License 0910-0338
Application.
807, subpart E.................. Premarket Notification 0910-0120
812............................. Investigational Device 0910-0078
Exemption.
814, subparts A through E....... Premarket Approval.... 0910-0231
814, subpart H.................. Humanitarian Use 0910-0332
Device; Humanitarian
Device Exemption.
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Dated: May 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-09338 Filed 5-6-19; 8:45 am]
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