top of page

USFDA Guidance: Medical Device Submissions "The Q-Submission Program"

Last Friday (02 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released final Administrative / Procedural guidance on "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program".

This guidance document provides information on how individuals or organizations can request feedback from the Food and Drug Administration (FDA) regarding different types of medical device applications.

These applications include Investigational Device Exemption (IDE), Premarket Approval (PMA), Humanitarian Device Exemption (HDE), Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)), 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).

It specifically covers INDs and BLAs for devices regulated as biological products under section 351 of the Public Health Service (PHS) Act.

The term “Q-Submission” or “Q-Sub” refers to the system used to track the collection of interactions as follows

  • Pre-Submissions (Pre-Subs)

  • Submission Issue Requests (SIRs)

  • Study Risk Determinations

  • Informational Meetings

  • Other Q-Submission Types

  • Other Uses of the Q-Submission Program

To know more about the general processes for the Q-Sub program click this LINK.


bottom of page