The final guidance on the US FDA’s Q-Submission (Q-Sub or Pre-Sub) Program, the process allowing medical device and IVD manufacturers to request and obtain FDA feedback before submitting their premarket applications for formal review, “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program ” was issued on May 7, 2019.

USA: Final FDA medical device Q-Submission guidance includes cybersecurity-related questions

The document maps out the timeline and the recommended content for each type of application/submission covered by the Q-Sub program, meaning:

  • Investigational Device Exemptions (IDEs);
  • Premarket Approvals (PMAs);
  • Humanitarian Device Exemptions (HDEs);
  • De Novo requests;
  • Premarket Notifications (510(k));
  • Clinical Laboratory Improvement Amendments (CLIA) Waivers, dual (510(k)) and CLIA Waiver by Application;
  • Accessory Classification Requests, and
  • certain Investigational New Drug (INDs) and Biologics License Applications (BLAs)

and provides an overview of the mechanisms available to submitters requesting feedback or a meeting with the FDA.

Noteworthy is the fact that FDA has expanded Appendix 2 and now includes cybersecurity-related questions among those that could be addressed via Q-Sub feedback, providing four practical examples.

The participation in the Q-Sub Program is voluntary. The meetings, conducted either in person or via teleconference, are meant to foster an open discussion between the FDA and the submitter regarding the technical, scientific and regulatory issues involving the medical device and can take place at different stages in a product’s development cycle.

The aforementioned guidance supersedes the 2017 (previous) version, and reflects changes to the Q-Sub Program under the Medical Device User Fee Amendments of 2017 (MDUFA IV).