A voluntary process to align early with FDA on classification, testing, and regulatory strategy—reducing risk, avoiding delays, and streamlining 510(k), De Novo, or PMA clearance.
The FDA’s Q‑Submission program provides a forum to discuss your regulatory strategy before submitting a 510(k), De Novo or PMA. A pre‑submission meeting allows sponsors to obtain feedback on classification, predicate selection, test plans and other regulatory questions. Although voluntary, pre‑subs are highly recommended for novel technologies, ambiguous predicate choices, first‑in‑class devices or complex software.
A complete package includes a cover letter identifying the device and requesting a pre‑submission meeting, a concise device description, development history, proposed verification and validation strategy, risk management summary and a list of specific questions. Include rationale for predicate selection and highlight any novel technologies or anticipated issues. Clearly state the preferred meeting format—written response, teleconference or in‑person.
After receiving the pre‑submission package, the FDA performs a 15‑day acceptance review to ensure administrative completeness. Meetings are typically scheduled 60–75 days after acceptance, and reviewers provide preliminary written responses five business days before the meeting. Following the meeting, the sponsor must submit meeting minutes within 15 days; the FDA will review and either concur or suggest corrections. These early interactions provide an opportunity to align on regulatory expectations and adjust your test plan before incurring costly studies.
Once you submit your 510(k), a substantive review begins. Reviewers may request additional information (AI) or raise questions via interactive review. When an AI request is issued, the submission is placed on hold, and the sponsor has 180 calendar days to respond. Missing this deadline results in withdrawal of the submission. During interactive review, respond promptly to clarifying questions and provide evidence or rationale as requested.
Ask clear, specific questions during pre‑subs to obtain actionable feedback. Include sufficient data (e.g., draft protocols, proposed acceptance criteria) to facilitate meaningful discussion. Maintain respectful and transparent communication throughout the review. Keep a log of all interactions, and use teleconferences to resolve complex questions quickly. Clear communication with the reviewer reduces the likelihood of surprise AI requests and streamlines the review process.
Early engagement with the FDA through the pre‑submission program clarifies regulatory expectations, identifies potential deficiencies and ultimately reduces time to clearance. By proactively managing communications during review, sponsors can avoid delays and maintain momentum toward product launch.
