FDA Regulation
Refuse to accept vs. hold letter vs. deficiency letter
What each FDA letter means, when it arrives, how long you have to respond, and what to do next.
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Refuse to accept (or eSTAR technical screening hold)
- When
- First 15 calendar days after the FDA receives the submission.
- What it means
- The submission is incomplete and review has not started.
- Response clock
- 180 days to send a complete submission, or it is withdrawn.
- Next step
- Add every missing element and resubmit.
Hold letter (510(k) additional information request)
- When
- During substantive review.
- What it means
- The reviewer has questions and the 510(k) is placed on hold.
- Response clock
- 180 calendar days to respond in full, or the 510(k) is considered withdrawn.
- Next step
- Answer each question with evidence, not promises.
Deficiency letter (De Novo or PMA)
- When
- During substantive review.
- What it means
- Major questions on a De Novo request or PMA.
- Response clock
- 180 days to respond in full, or the submission is considered withdrawn.
- Next step
- Answer each deficiency with evidence.
Sources: FDA Refuse to Accept Policy for 510(k)s guidance, FDA eSTAR program, and FDA guidance on additional information requests.
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