Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 18947-18948 [2024-05580]

Download as PDF Federal Register / Vol. 89, No. 52 / Friday, March 15, 2024 / Notices determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/ mL, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to NUCYNTA (tapentadol hydrochloride) solution, eq 20 mg base/ mL, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: March 12, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024–05582 Filed 3–14–24; 8:45 am] BILLING CODE 4164–01–P 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No. FDA–2018–D–1774] Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.’’ This draft guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device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 This draft guidance, when finalized, is intended to supersede the document entitled ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The QSubmission Program’’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., khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 18:17 Mar 14, 2024 Jkt 262001 informal communication vs. PreSubmission 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 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 18947 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-201509-18/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 E:\FR\FM\15MRN1.SGM 15MRN1 18948 Federal Register / Vol. 89, No. 52 / Friday, March 15, 2024 / Notices 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 khammond on DSKJM1Z7X2PROD with NOTICES 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 QSubmission 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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-bloodbiologics/guidance-complianceregulatory-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 CDRH-Guidance@fda.hhs.gov 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 No. 21 CFR part or guidance Topic 807, subpart E ............................................................................................. 814, subparts A through E ........................................................................... 814, subpart H ............................................................................................. 812 ............................................................................................................... 860, subpart D ............................................................................................. ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’. ‘‘Administrative Procedures for CLIA Categorization’’ and ‘‘Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices’’. ‘‘Medical Device Accessories—Describing Accessories and Classification Pathways’’. Form FDA 3601 ‘‘Medical Device User Fee Cover Sheet’’; Form FDA 3601(a), the ‘‘Device Facility User Fee Cover Sheet;’’ ‘‘FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act’’. ‘‘Center for Devices and Radiological Health Appeals Processes’’ ............ ‘‘Emergency Use Authorization of Medical Products and Related Authorities’’. 312 ............................................................................................................... 601 ............................................................................................................... Premarket notification ................................................................................. Premarket approval .................................................................................... Humanitarian Use Devices; Humanitarian Device Exemption ................... Investigational Device Exemption .............................................................. De Novo classification process .................................................................. Q-submissions and Early Payor Feedback Request Programs for Medical Devices. CLIA Administrative Procedures; CLIA Waivers ........................................ 0910–0120 0910–0231 0910–0332 0910–0078 0910–0844 0910–0756 Accessories ................................................................................................ 0910–0823 Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet—Form FDA 3601 and Form 3601(a); 513(g) Request for Information. 0910–0511 Appeals Process ......................................................................................... Emergency Use Authorization .................................................................... 0910–0738 0910–0595 Investigational New Drug Application ......................................................... Biologics License Application ..................................................................... 0910–0014 0910–0338 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 VerDate Sep<11>2014 18:17 Mar 14, 2024 Jkt 262001 PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 E:\FR\FM\15MRN1.SGM 15MRN1 0910–0607

Agencies

[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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.