Acceptance review and Refuse to Accept
The acceptance review is FDA's first look at a 510(k). Its purpose is to assess whether the submission is administratively complete — whether it contains the information FDA needs to conduct a substantive review. It is not an assessment of the device. A submission that fails is designated Refuse to Accept. It is not rejected, and no decision on the device has been made.
FDA Refuse to Accept Policy for 510(k)s, 21 April 2022
At a glance
| What it checks | Administrative completeness, not the merits of the device. |
|---|---|
| How long | Within 15 calendar days of FDA receiving the submission. |
| When the clock starts | Only once the user fee is paid and a valid eCopy has been received. |
| If FDA misses the 15 days | The submitter is notified that the submission is under substantive review. FDA may still request the missing information later. |
| If refused | 180 calendar days to fully address the deficiencies. Miss it and the submission is considered withdrawn and deleted. |
| New user fee to respond? | No. |
| Does the review clock run during an RTA hold? | No. It does not start while a submission is on hold or designated RTA. |
| Does this apply to eSTAR? | No. eSTAR submissions go through technical screening instead. See below. |
The three possible outcomes
- The submission is accepted, and moves to substantive review.
- The submission is refused, and is placed on RTA hold with a checklist identifying what is missing.
- FDA did not complete the acceptance review within 15 calendar days, and the submission is under substantive review by default.
FDA states that it is sufficient to submit and address only the information requested in the notification. The response goes into the file under the originally assigned 510(k) number. A new submission and a new user fee are not necessary, and the entire submission does not need re-sending unless FDA says otherwise.
On receipt of the response, FDA conducts the acceptance review again, within 15 calendar days.
eSTAR is screened, not refused
Since eSTAR became mandatory for 510(k) submissions on 1 October 2023, the acceptance review described above applies in practice only to eCopy submissions.
An eSTAR goes through virus scanning and technical screening instead, anticipated within 15 days. A failure places the submission on hold, with the same 180-day limit and the same consequence: the file is closed.
The deadline and the outcome are therefore identical. What differs is the gate, the name, and the fact that the CDRH Portal blocks an incomplete eSTAR before it is ever submitted.
Questions people ask
Does an RTA mean our device was rejected?
No. No decision about the device has been made. The submission was found administratively incomplete and FDA has identified what is missing.
Do we pay again to respond?
No. FDA states a new submission and new user fee are not necessary. Respond under the original 510(k) number.
What are the most common reasons for a refusal?
FDA publishes the acceptance checklists it applies — separate ones for Traditional, Abbreviated and Special 510(k)s — but does not publish a breakdown of which items fail most often. The checklists are the authoritative list of what is assessed.
Does the 90-day review goal include the acceptance review?
FDA's goal is 90 FDA Days, calculated as calendar days between receipt and decision, excluding days the submission was on hold for an Additional Information request. Time on RTA hold does not count, because the review clock has not started.
Can we ask FDA about an RTA before responding?
A Submission Issue Request under the Q-Submission Program is the formal route for feedback on how to address a hold or a deficiency on a filed submission.