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Food and Drug Administration, HHS.
Notice of availability.
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).
The announcement of the guidance is published in the Federal Register on May 7, 2019.
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
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.
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.
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.
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.
This guidance is being issued consistent with FDA's good guidance ( printed page 19925) 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.
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 CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1677 to identify the guidance you are requesting.
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:
| 21 CFR Part or guidance | Topic | OMB control No. |
|---|---|---|
| “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” | Q-submissions | 0910-0756 |
| “De Novo Classification Process (Evaluation of Automatic Class III Designation)” | De Novo Requests | 0910-0844 |
| “Recommendations: Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” | CLIA Waivers | 0910-0598 |
| “Medical Device Accessories—Describing Accessories and Classification Pathways” | Accessories | 0910-0823 |
| 312 | Investigational New Drug Application | 0910-0014 |
| 601 | Biologics License Application | 0910-0338 |
| 807, subpart E | Premarket Notification | 0910-0120 |
| 812 | Investigational Device Exemption | 0910-0078 |
| 814, subparts A through E | Premarket Approval | 0910-0231 |
| 814, subpart H | Humanitarian Use Device; Humanitarian Device Exemption | 0910-0332 |
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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