Overview
FDA Q-Submission (Pre-IDE) meetings are formal meetings or official written correspondence between the FDA and investigators who seek FDA feedback on IDE applications (and other types of device submissions, such as humanitarian device exemptions (HDE) and De Novo requests) or study risk determinations. Q-Submissions can increase the likelihood of a successful IDE application, shorten FDA review time, or help investigators address FDA safety concerns with an IDE application.
Types of Q-Submissions
Review the FDA Guidance: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program external site (opens in a new window) (June 2023)
- Pre-Submissions: can be used to discuss potential or planned IDEs and can include discussions of clinical studies.
- Study Risk Determinations: submitted to request the FDA's determination for whether a planned medical device clinical study is significant risk (SR), nonsignificant risk (NSR), or exempt from IDE regulations as defined by the IDE regulations (21 CFR part 812).
Formal Meetings
Two types of Formal Meetings, Agreement Meetings and Determination Meetings, were previously established by the FDA Modernization Act (FDAMA) to facilitate interaction with the FDA and are defined in Sections 520(g)(7) and 513(a)(3)(D) of the Federal Food, Drug and Cosmetic Act respectively. Additional information about Determination and Agreement meetings can be found in the FDA guidance Early Collaboration Meetings Under the FDA Modernization Act (FDAMA), Final Guidance for Industry and CDRH Staff