Navigating the FDA 510(k) Review: What to Expect After Submission

After submitting a 510(k) application to the FDA, the review process follows four key milestones: Acknowledgment of Receipt, Acceptance Review, Substantive Review, and the 510(k) Decision Letter. First, the FDA assigns a unique identification number and verifies proper fee payment and submission validity. If any issues arise, the applicant has 180 days to resolve them. Next, the submission undergoes an Acceptance Review to determine if it is complete. eSTAR submissions typically avoid the "Refuse to Accept" (RTA) process, while eCopy submissions are checked against an acceptance checklist. Within 15 days, the FDA notifies applicants whether the submission is accepted for substantive review, placed on hold for deficiencies, or still under review.

The Substantive Review involves an in-depth evaluation by the Lead Reviewer, who communicates deficiencies through either an Interactive Review, allowing quick resolution, or an Additional Information (AI) Request, which places the submission on hold. Applicants have 180 days to respond to an AI Request before withdrawal. The FDA aims to issue a decision within 90 days (excluding hold periods), determining whether the device is "Substantially Equivalent" (SE) or "Not Substantially Equivalent" (NSE). If the review extends beyond 100 days, the FDA provides written feedback and a meeting to discuss outstanding issues. Staying proactive throughout the process is crucial for ensuring timely clearance.