Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: – Final Guidance for Industry and Food and Drug Administration Staff

Issue Date: May 29, 2025
Issued by: Center for Devices and Radiological Health
Topic(s): Administrative / Procedural, Investigational Device Exemption (IDE)
Status: Final

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: – Final Guidance for Industry and Food and Drug Administration Staff

The purpose of this guidance document is to provide an overview of the mechanisms available to submitters through which they can request interactions with the Food and Drug Administration (FDA) related to medical device submissions. These interactions can include written feedback or a meeting related to 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 Applications (CW), Dual 510(k) and CLIA Waiver by Application Submissions (Duals), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act ).

Download the Guidance Document