FDA conducts a 15-day acceptance review to confirm De Novo completeness. Failing criteria triggers an RTA and delays. Use FDA’s checklist as a QA gate to catch missing labeling, reports, or risk linkages before submission.
The FDA performs a 15-day acceptance review to determine if your De Novo submission is administratively complete. Failing to meet the acceptance criteria results in a Refuse to Accept (RTA), which pauses progress and delays your regulatory timelines.
The Acceptance Review for De Novo Classification Requests guidance and its checklist outline the minimum elements required at intake. It is critical to build your internal RTA precheck process around this list rather than relying on FDA reviewers to point out basic omissions.
Run the acceptance checklist as a formal Quality Assurance (QA) gate before submission. This is the fastest and most effective way to protect your submission timeline and avoid costly delays caused by an RTA.
