FDA Issues Draft Guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

FDA Issues Draft Guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

Today, the U.S. Food and Drug Administration issued the draft guidance document, "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." This guidance will explain the ways submitters can request feedback from, or a meeting with, FDA regarding potential or planned medical device or device-led combination product submissions. The FDA Q-Submission Program is a system that tracks different types of requests for feedback from or interaction with FDA regarding planned regulatory submissions as well as requests for certain types of formal designations that are not standalone marketing submissions or research authorizations.

The types of Q-Submissions covered in the guidance include:

• Pre-Submissions (Pre-Subs)
• Submission Issue Requests (SIRs)
• Study Risk Determinations (SRDs)
• Informational Meetings

This guidance, particularly the Pre-Submission and Informational Meeting options, should be considered prior to submitting the following types of regulatory submissions: 

• 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 Applications  
• Dual 510(k) and CLIA Waiver by Application Submissions (Duals)
• Certain Investigational New Drug (IND) applications and Biologics License Applications submitted to the Center for Biologics Evaluation and Research (CBER)

Additionally, this guidance provides information for submitting other types of requests tracked as Q-submissions, which have separate guidance documents covering their specific policies. These include PMA Day 100 Meetings, Designation Requests for a Breakthrough Device, and Requests for Accessory Classification.

The guidance also includes information about other situations for which industry can obtain feedback from FDA. These situations include, but are not limited to: 1) general policy, procedure, or simple review clarification questions that can be readily answered by FDA staff; and 2) discussion of issues identified while an IDE, IND or marketing submission is under active FDA review. When final, this guidance will replace the Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff guidance issued in September 2017.

We welcome your comments and suggestions regarding this draft guidance. The comment period will be open for 60 days in the Federal Register under Docket Number: FDA-2018-D-1774.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.

Food and Drug Administration
Center for Devices and Radiological Health