[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

[[Page 19924]]

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:

------------------------------------------------------------------------
                                                            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]
 BILLING CODE 4164-01-P