83 FR 26482 - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 110 (June 7, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 110 (June 7, 2018)
| Page Range | 26482-26483 | |
| FR Document | 2018-12223 |
[Federal Register Volume 83, Number 110 (Thursday, June 7, 2018)] [Notices] [Pages 26482-26483] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12223] ----------------------------------------------------------------------- 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No. FDA-2018-D-1774] Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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 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draft document entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Draft Guidance for Industry and Food and Drug Administration Staff.'' This draft guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential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 This draft guidance, when finalized, is intended to supersede the document entitled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings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 This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by August 6, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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] BILLING CODE 4164-01-P
![26482 Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices
Pharmaceutical informed FDA that it investigational new drug (IND) Instructions: All submissions received
did not want approval of the ANDA applications and biologics license must include the Docket No. FDA–
withdrawn. Because Sun applications (BLAs). This draft 2018–D–1774 for ‘‘Requests for
Pharmaceutical timely requested that guidance, when finalized, is intended to Feedback and Meetings for Medical
approval of this ANDA not be supersede the document entitled Device Submissions: The Q-Submission
withdrawn, the approval of ANDA ‘‘Requests for Feedback on Medical Program; Draft Guidance for Industry
077483 is still in effect. Device Submissions: The Pre- and Food and Drug Administration
FOR FURTHER INFORMATION CONTACT: Submission Program and Meetings with Staff.’’ Received comments will be
Trang Tran, Center for Drug Evaluation Food and Drug Administration Staff’’ placed in the docket and, except for
and Research, Food and Drug issued on September 29, 2017. This those submitted as ‘‘Confidential
Administration, 10903 New Hampshire draft guidance is not final nor is it in Submissions,’’ publicly viewable at
Ave., Bldg. 75, Rm. 1671, Silver Spring, effect at this time. https://www.regulations.gov or at the
MD 20993–0002, 240–402–7945. DATES: Submit either electronic or Dockets Management Staff between 9
SUPPLEMENTARY INFORMATION: In the written comments on the draft guidance a.m. and 4 p.m., Monday through
Federal Register of Friday, February 23, by August 6, 2018 to ensure that the Friday.
Agency considers your comment on this • Confidential Submissions—To
2018 (83 FR 8089), appearing on page
draft guidance before it begins work on submit a comment with confidential
8089 in FR Doc. 2018–03700, the
the final version of the guidance. information that you do not wish to be
following correction is made: made publicly available, submit your
1. On page 8090, the entry for ANDA ADDRESSES: You may submit comments comments only as a written/paper
077483 in the table is removed. on any guidance at any time as follows: submission. You should submit two
Dated: June 1, 2018. Electronic Submissions copies total. One copy will include the
Leslie Kux, information you claim to be confidential
Associate Commissioner for Policy.
Submit electronic comments in the with a heading or cover note that states
following way: ‘‘THIS DOCUMENT CONTAINS
[FR Doc. 2018–12220 Filed 6–6–18; 8:45 am]
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
BILLING CODE 4164–01–P
https://www.regulations.gov. Follow the Agency will review this copy, including
instructions for submitting comments. the claimed confidential information, in
Comments submitted electronically, its consideration of comments. The
DEPARTMENT OF HEALTH AND
including attachments, to https:// second copy, which will have the
HUMAN SERVICES
www.regulations.gov will be posted to claimed confidential information
Food and Drug Administration the docket unchanged. Because your redacted/blacked out, will be available
comment will be made public, you are for public viewing and posted on
[Docket No. FDA–2018–D–1774] solely responsible for ensuring that your https://www.regulations.gov. Submit
comment does not include any both copies to the Dockets Management
Requests for Feedback and Meetings
confidential information that you or a Staff. If you do not wish your name and
for Medical Device Submissions: The
third party may not wish to be posted, contact information to be made publicly
Q-Submission Program; Draft
such as medical information, your or available, you can provide this
Guidance for Industry and Food and
anyone else’s Social Security number, or information on the cover sheet and not
Drug Administration Staff; Availability
confidential business information, such in the body of your comments and you
AGENCY: Food and Drug Administration, as a manufacturing process. Please note must identify this information as
HHS. that if you include your name, contact ‘‘confidential.’’ Any information marked
ACTION: Notice of availability. information, or other information that as ‘‘confidential’’ will not be disclosed
identifies you in the body of your except in accordance with 21 CFR 10.20
SUMMARY: The Food and Drug comments, that information will be and other applicable disclosure law. For
Administration (FDA or Agency) is posted on https://www.regulations.gov. more information about FDA’s posting
announcing the availability of a draft • If you want to submit a comment of comments to public dockets, see 80
document entitled ‘‘Requests for with confidential information that you FR 56469, September 18, 2015, or access
Feedback and Meetings for Medical do not wish to be made available to the the information at: https://www.gpo.gov/
Device Submissions: The Q-Submission public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
Program; Draft Guidance for Industry written/paper submission and in the 23389.pdf.
and Food and Drug Administration manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Staff.’’ This draft guidance document Submissions’’ and ‘‘Instructions’’). read background documents or the
provides an overview of the electronic and written/paper comments
mechanisms available to applicants Written/Paper Submissions
received, go to https://
through which they can request Submit written/paper submissions as www.regulations.gov and insert the
feedback from or a meeting with FDA follows: docket number, found in brackets in the
regarding potential or planned medical • Mail/Hand delivery/Courier (for heading of this document, into the
device investigational device exemption written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
(IDE) applications, premarket approval Management Staff (HFA–305), Food and and/or go to the Dockets Management
(PMA) applications, humanitarian Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
device exemption (HDE) applications, Lane, Rm. 1061, Rockville, MD 20852.
sradovich on DSK3GMQ082PROD with NOTICES
Rockville, MD 20852.
evaluation of automatic class III • For written/paper comments You may submit comments on any
designations (de novo requests), submitted to the Dockets Management guidance at any time (see 21 CFR
premarket notification (510(k)) Staff, FDA will post your comment, as 10.115(g)(5)).
submissions, Clinical Laboratory well as any attachments, except for An electronic copy of the guidance
Improvement Amendments (CLIA) information submitted, marked and document is available for download
Waiver by Application, Accessory identified, as confidential, if submitted from the internet. See the
Classification Requests, and certain as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION section for
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![Federal Register / Vol. 83, No. 110 / Thursday, June 7, 2018 / Notices 26483
information on electronic access to the related to the scheduling of Pre-Sub These collections of information are
guidance. Submit written requests for a meetings and a new performance goal subject to review by the Office of
single hard copy of the draft guidance on the timing of FDA feedback on Pre- Management and Budget (OMB) under
document entitled ‘‘Requests for Subs. This guidance reflects those the Paperwork Reduction Act of 1995
Feedback and Meetings for Medical changes and clarifies other elements of (44 U.S.C. 3501–3520). The collections
Device Submissions: The Q-Submission the Q-Sub program. of information in 21 CFR part 803 are
Program; Draft Guidance for Industry This draft guidance document approved under OMB control number
and Food and Drug Administration provides an overview of the 0910–0437; the collections of
Staff’’ to the Office of the Center mechanisms available to applicants information in 21 CFR part 807, subpart
Director, Guidance and Policy through which they can request E are approved under OMB control
Development, Center for Devices and feedback from or a meeting with FDA number 0910–0120; the collections of
Radiological Health, Food and Drug regarding potential or planned medical information in 21 CFR part 812 are
Administration, 10903 New Hampshire device IDE applications, PMA approved under OMB control number
Ave., Bldg. 66, Rm. 5431, Silver Spring, applications, HDE applications, de novo 0910–0078; the collections of
MD 20993–0002 or the Office of requests, 510(k) Submissions, CLIA information in 21 CFR part 814 are
Communication, Outreach, and Waiver by Application, Accessory approved under OMB control number
Development, Center for Biologics Classification Requests, and certain 0910–0231; and the collections of
Evaluation and Research, Food and INDs and BLAs. information for ‘‘Request for Feedback
Drug Administration, 10903 New II. Significance of Guidance on Medical Device Submissions’’ are
Hampshire Ave., Bldg. 71, Rm. 3128, approved under OMB control number
Silver Spring, MD 20993–0002. Send This draft guidance is being issued 0910–0756.
one self-addressed adhesive label to consistent with FDA’s good guidance
practices regulation (21 CFR 10.115). Dated: June 1, 2018.
assist that office in processing your Leslie Kux,
request. The draft guidance, when finalized, will
represent the current thinking of FDA Associate Commissioner for Policy.
FOR FURTHER INFORMATION CONTACT: J. on ‘‘Requests for Feedback and Meetings [FR Doc. 2018–12223 Filed 6–6–18; 8:45 am]
Allen Hill, Center for Devices and for Medical Device Submissions: The Q- BILLING CODE 4164–01–P
Radiological Health, Food and Drug Submission Program; Draft Guidance for
Administration, 10903 New Hampshire Industry and Food and Drug
Ave., Bldg. 66, Rm. 5627, Silver Spring, Administration Staff.’’ It does not DEPARTMENT OF HEALTH AND
MD 20993–0002, 301–796–7086; or establish any rights for any person and HUMAN SERVICES
Stephen Ripley, Center for Biologics is not binding on FDA or the public.
Evaluation and Research, Food and You can use an alternative approach if Food and Drug Administration
Drug Administration, 10903 New it satisfies the requirements of the [Docket No. FDA–2018–N–1823]
Hampshire Ave., Bldg. 71, Rm. 7301, applicable statutes and regulations. This
Silver Spring, MD 20993, 240–402– guidance is not subject to Executive Pulmonary-Allergy Drugs Advisory
7911. Order 12866. Committee; Notice of Meeting;
SUPPLEMENTARY INFORMATION: Establishment of a Public Docket;
III. Electronic Access Request for Comments
I. Background Persons interested in obtaining a copy
The pre-IDE program was established of the draft guidance may do so by AGENCY: Food and Drug Administration,
in 1995, to provide applicants a downloading an electronic copy from HHS.
mechanism to obtain FDA feedback on the internet. A search capability for all ACTION: Notice, establishment of a
future IDE applications prior to their Center for Devices and Radiological public docket; request for comments.
submission. Over time, the pre-IDE Health guidance documents is available SUMMARY: The Food and Drug
program evolved to include feedback on at https://www.fda.gov/MedicalDevices/ Administration (FDA) announces a
PMA applications, HDE applications, de DeviceRegulationandGuidance/ forthcoming public advisory committee
novo requests, and 510(k) submissions, GuidanceDocuments/default.htm. This meeting of the Pulmonary-Allergy Drugs
as well as to address whether a clinical draft guidance is also available at Advisory Committee. The general
study requires submission of an IDE. https://www.fda.gov/BiologicsBlood function of the committee is to provide
To capture this evolution, the Vaccines/GuidanceCompliance advice and recommendations to FDA on
Secretary of Health and Human RegulatoryInformation/default.htm or regulatory issues. The meeting will be
Services’ 2012 Commitment Letter to https://www.regulations.gov. Persons open to the public. FDA is establishing
Congress regarding the Medical Device unable to download an electronic copy a docket for public comment on this
User Fee Amendments of 2012 (MDUFA of ‘‘Requests for Feedback and Meetings document.
III) included FDA’s commitment to for Medical Device Submissions: The Q-
institute a structured process for Submission Program; Draft Guidance for DATES: The meeting will be held on July
managing these interactions, referring to Industry and Food and Drug 25, 2018, from 8 a.m. to 4 p.m.
them as ‘‘Pre-Submissions.’’ The Pre- Administration Staff’’ may send an ADDRESSES: FDA White Oak Campus,
Submission Guidance, published email request to CDRH-Guidance@ 10903 New Hampshire Ave., Bldg. 31
February 18, 2014, implemented the fda.hhs.gov to receive an electronic Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
sradovich on DSK3GMQ082PROD with NOTICES
broader Q-Submission (Q-Sub) Program, copy of the document. Please use the
which includes Pre-Submissions (Pre- document number 1677 to identify the Answers to commonly asked questions
Subs), as well as additional guidance you are requesting. including information regarding special
opportunities to engage with FDA. accommodations due to a disability,
As part of the Medical Device User IV. Paperwork Reduction Act of 1995 visitor parking, and transportation may
Fee Amendments of 2017 (MDUFA IV), This draft guidance also refers to be accessed at: https://www.fda.gov/
industry and the Agency agreed to previously approved information AdvisoryCommittees/AboutAdvisory
refine the Q-Sub Program with changes collections found in FDA regulations. Committees/ucm408555.htm.
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Document Created: 2018-06-07 00:50:01
Document Modified: 2018-06-07 00:50:01
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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. | |
| FR Citation | 83 FR 26482 |
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