Navigating the FDA Review Process: What to Expect After Submitting Your Medical Device Application

A person types on a laptop, processing a new application with focused attention.

Once a 510(k) submission is received, the FDA issues an acknowledgment letter with a unique submission number, provided the user fee is paid. A valid eCopy or eSTAR is included. The next stage, Acceptance Review, determines whether the submission is complete. eSTAR submissions generally skip the Refuse to Accept (RTA) process unless incomplete, while eCopy submissions are assessed using a standardized checklist.

Submitters have 180 days to address any deficiencies or risk withdrawal of the application.

During the Substantive Review, the FDA conducts a detailed device evaluation. If issues arise, they may initiate an Interactive Review (minor issues resolved quickly) or issue an Additional Information (AI) Request, which places the submission on hold. The FDA aims to issue a decision within 90 days (excluding hold time), declaring the device substantially equivalent (SE) or not substantially equivalent (NSE). If a decision isn’t made within 100 days, a Missed MDUFA Communication is sent, outlining remaining issues and next steps. Proactive responses and organized submissions are key to smooth clearance.