FDA Q-Submission (Pre-Sub) Guidance

01 What the document says

The Q-Submission program is the formal channel for interacting with CDRH and CBER about a device before or during a premarket submission. This guidance, finalized in May 2025 and superseding the 2023 version, describes the types of Q-Submissions, what each should contain, and the timelines FDA aims to meet. The program is voluntary and covers IDEs, PMAs, De Novo requests, 510(k)s, HDEs, CLIA waiver applications, and dual submissions.

The main types are the Pre-Submission (Pre-Sub), in which a sponsor asks specific questions about a planned study, test method, or submission strategy and receives written feedback and, if requested, a meeting; the Submission Issue Request, used to resolve deficiencies in a submission already under review; the Informational Meeting, used to brief FDA without asking for feedback; and the Study Risk Determination, which asks FDA whether a planned study is significant risk, non-significant risk, or exempt from IDE requirements. The guidance explains how to frame questions, what background to include, and how FDA feedback can be relied on later.

For IVD sponsors the Pre-Sub is the usual vehicle for getting agreement on a clinical protocol: the intended-use statement, comparator, site types, operator qualifications, sample size rationale, and statistical analysis plan can all be put in front of the review division before enrollment. The guidance also addresses how many questions a single Pre-Sub should carry and when a follow-up Pre-Sub is appropriate.

02 What it means when you plan a study

• A Pre-Sub adds a defined waiting period before enrollment but typically saves more than that by removing comparator, population, and sample-size questions that would otherwise surface as deficiencies after the study is complete.
• Bring a full draft protocol and statistical analysis plan, not a concept; FDA's feedback is only as specific as the questions and materials you provide.
• For CLIA waiver and dual submissions, the Pre-Sub is the place to confirm site types, operator qualifications, and the accuracy comparison approach, since those decisions are hard to change once sites are contracted.
• A Study Risk Determination settles whether the study needs an IDE; most IVD studies using leftover specimens or non-invasive collection are exempt, but confirming it avoids a late IRB question.
• Build the Pre-Sub timeline into the overall schedule: protocol drafting, FDA feedback, protocol revision, and then IRB submission are sequential, and the IRB generally wants the FDA-informed version.

03 Pathways it applies to

• 510(k) Clinical Studies
• CLIA Waiver Studies
• Dual Submission Studies

Source document: Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (fda.gov).