[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)]
[Notices]
[Pages 26482-26483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12223]


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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Submissions: The Q-Submission Program; Draft Guidance for Industry and 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 draft document entitled ``Requests for Feedback 
and Meetings for Medical Device Submissions: The Q-Submission Program; 
Draft Guidance for Industry and Food and Drug Administration Staff.'' 
This draft guidance document provides an overview of the mechanisms 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 
(PMA) applications, 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 Application, Accessory 
Classification Requests, and certain investigational new drug (IND) 
applications and biologics license applications (BLAs). This draft 
guidance, when finalized, is intended to supersede the document 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. This draft guidance is not final 
nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by August 6, 2018 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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; Draft Guidance for 
Industry and Food and Drug Administration Staff.'' 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

[[Page 26483]]

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; Draft Guidance for Industry and Food and Drug 
Administration Staff'' to the Office of the Center Director, 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 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: J. Allen Hill, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5627, Silver Spring, MD 20993-0002, 301-796-7086; 
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 draft 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 IDE 
applications, PMA applications, HDE applications, de novo requests, 
510(k) Submissions, CLIA Waiver by Application, Accessory 
Classification Requests, and certain INDs and BLAs.

II. Significance of Guidance

    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; Draft Guidance for Industry and Food and Drug Administration 
Staff.'' 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 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft 
guidance is also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download 
an electronic copy of ``Requests for Feedback and Meetings for Medical 
Device Submissions: The Q-Submission Program; Draft Guidance for 
Industry and Food and Drug Administration Staff'' 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 draft guidance also refers to previously approved information 
collections found in FDA regulations. 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 21 CFR part 803 are approved under OMB 
control number 0910-0437; the collections of information in 21 CFR part 
807, subpart E are approved under OMB control number 0910-0120; the 
collections of information in 21 CFR part 812 are approved under OMB 
control number 0910-0078; the collections of information in 21 CFR part 
814 are approved under OMB control number 0910-0231; and the 
collections of information for ``Request for Feedback on Medical Device 
Submissions'' are approved under OMB control number 0910-0756.

    Dated: June 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12223 Filed 6-6-18; 8:45 am]
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