FDA’s De Novo review spans acceptance, substantive review, and decision—Grant, Decline, or alternate pathway. Stay review-ready with clear risk-to-evidence mapping, timely responses, and PreSubs to align expectations early.
The FDA’s De Novo review process includes several key stages: acceptance (Refuse to Accept or RTA screening), substantive review, possible interactive review, and final decision. Under the Medical Device User Fee Amendments V (MDUFA V) for fiscal years 2023–2027, the FDA tracks performance goals for De Novo decisions, with enhancements implemented throughout the review cycle.
It is critical to plan for FDA interactions and be prepared to respond quickly to any deficiencies identified during the review.
Ensure your submission maintains clear traceability from identified risks to mitigations, supporting evidence, and proposed special controls. This traceability facilitates a focused and efficient review process.
Engaging in Pre-Submission (PreSub) meetings with the FDA helps align expectations early, reducing surprises during review and improving the likelihood of a smooth decision.
