The U.S. FDA has issued final guidance that details its Q-submission program, a voluntary avenue for developers of medical devices to collaborate with and get feedback from the agency before committing to a premarket submission. The program is available for a broad range of medical device and device-led combination product submissions, including investigational device exemption, premarket approval, humanitarian device exemption, de novo requests, and 510(k) premarket notifications.
The official statement from the FDA lists that the purpose of the guidance is to provide an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with the FDA regarding potential or planned medical device investigational device exemption applications, premarket approval applications, humanitarian device exemption 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), accessory classification requests, and certain investigational new drug applications and biologics license applications submitted to the Center for Biologics Evaluation and Research.
“Early interaction with FDA on planned nonclinical and clinical studies and careful consideration of FDA’s feedback may improve the quality of subsequent submissions, shorten total review times, and facilitate the development process for new devices,” the FDA writes in the final guidance, Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.
A pre-submission (pre-sub) begins with a formal written request from the submitter. Productive pre-subs contain “clear, specific questions regarding review issues,” according to the FDA, and are submitted before any planned testing takes place. The FDA will then respond with written feedback or schedule an in-person or teleconference meeting for additional discussion. The agency committed to completing its review within 15 days and providing written feedback in 70-90 days, depending on the type of Q-submission.
In addition to pre-subs, the Q-submission program also can be used to address issues conveyed in a marketing submission hold letter (submission issue request), determine the level of risk for a planned medical device clinical study (study risk determination), or to share information with the FDA without obtaining feedback (informational meeting).
The final guidance includes recommended background information and sample questions to help guide submitters towards a productive pre-sub process, a table detailing the review timeline for different submission types, a checklist used by the FDA during its acceptance process, and example meeting minutes.
The FDA will also hold a June 11 webinar to provide more information to submitters. The agency is also accepting feedback on the final guidance at www.regulations.gov (docket FDA-2018-D-1774).