Usage Examples
- Treat RTA risk as an assembly problem, not a substantial equivalence problem.
- The old RTA checklist is not the gate anymore; the Portal rejects the file before a reviewer opens it.
- FDA held us at technical screening because the software description question had no attachment behind it.
What is Refuse to Accept (RTA)?
Refuse to Accept is FDA's administrative decision that a device premarket submission is too incomplete to enter substantive review, a completeness gate applied before any scientific assessment of the device begins.
Refuse to Accept exists because CDRH cannot afford to spend scientific review capacity opening files that are merely incomplete. A 510(k) carries a fixed list of required content under 21 CFR 807.87, and Refuse to Accept is the threshold check that separates a question of assembly from the question that actually matters: whether the device is substantially equivalent to its predicate.
Refuse to Accept covers completeness and administrative form: whether the labeling, the 510(k) summary or statement, the financial certification, and the truthful-and-accurate statement are present and sit where a reviewer expects them. Refuse to Accept does not cover the merits. An accepted submission can still end in a Not Substantially Equivalent determination, and a refused one says nothing about the strength of the device's evidence.
Refuse to Accept has largely moved off the 510(k) front door since eSTAR became mandatory, with De Novo requests following on October 1, 2025. FDA states that eSTAR submissions are not anticipated to undergo an RTA process, because the CDRH Portal verifies completeness automatically. Virus scanning and a technical screening run instead, anticipated within 15 days of receipt, and only once the user fee is paid.
Not to be confused with
- Not Substantially Equivalent (NSE)
- NSE is the decision on the merits, reached after reviewers read the predicate comparison and the performance data. Refuse to Accept is reached before anyone reads them, and it is curable by resubmission rather than final.
- Technical screening
- technical screening is the eSTAR-era successor to RTA and checks something different: whether the responses accurately describe the device and whether each applicable attachment-type question actually carries a relevant attachment. RTA checked for presence of content; screening checks that content against the answers.
- Additional Information (AI) request
- an AI request comes out of substantive review and means reviewers read the submission and need more. Refuse to Accept means the submission never entered review at all, so the two consume different clocks and different remediation work.
- Complete Response Letter
- a CRL is the drug and biologic decision letter issued by CDER or CBER after a marketing application is reviewed. Refuse to Accept is a device-side gate that operates before review. Different center, different stage, different remedy.
The obligations that decide whether a device submission survives the completeness gate.
What you must do
- 1Include proposed labels, labeling, and advertisements sufficient to describe the device, its intended use, and the directions for its use21 CFR 807.87
- 2Include the financial certification or disclosure statement required by part 54, plus the statement that all data and information submitted are truthful and accurate and that no material fact has been omitted21 CFR 807.87
- 3Confirm the template header reads "eSTAR COMPLETE" before transmitting, because the CDRH Portal will not accept an eSTAR still marked incomplete and one sent by mail or ESG while incomplete is placed on hold for up to 180 daysFDA eSTAR Program, Section G
- 4Give every applicable attachment-type question at least one relevant attachment, and keep dropdown responses consistent with the device as built, since technical screening verifies bothElectronic Submission Template for Medical Device 510(k) Submissions, Section V
- 5Pay the appropriate user fee, because FDA intends to begin technical screening only for electronic submissions where it has been paid, within 15 days of receiptElectronic Submission Template for Medical Device 510(k) Submissions, Section V
- 6Prepare De Novo classification requests as eSTAR electronic submissions for filings on or after October 1, 2025Electronic Submission Template for Medical Device De Novo Requests, Section VI.B
Common mistakes
Running an obsolete RTA checklist as the preparation plan
FDA states eSTAR submissions are not anticipated to undergo an RTA process, and the gate moved to automated Portal verification plus a 15-day technical screening. Teams rehearsing the old acceptance checklist prepare for a gate that no longer fires and skip what screening actually inspects: whether each attachment belongs to its question and whether the answers describe the real device.
Reading acceptance as validation of the submission
clearing the completeness gate says only that the file is assembled. Substantial equivalence still turns on same intended use plus either the same technological characteristics or ones raising no different questions of safety and effectiveness (21 CFR 807.100(b)). Effort spent perfecting the container instead of the predicate argument buys an accepted submission that later goes NSE.
Letting the user fee lag the filing
FDA intends to begin technical screening only where the appropriate user fee has been paid, so an unpaid submission sits with no clock running and no deficiency to fix. The delay is invisible in the file itself, which is why it usually gets discovered when someone asks why nothing has happened in three weeks.
When This Matters
- Treat RTA risk as an assembly problem, not a substantial equivalence problem.
- The old RTA checklist is not the gate anymore; the Portal rejects the file before a reviewer opens it.
- FDA held us at technical screening because the software description question had no attachment behind it.
Frequently Asked Questions
No. Refuse to Accept is an acceptance-level decision about completeness, not a scientific verdict on the device, and the submission can be corrected and resubmitted. The scientific rejection is a Not Substantially Equivalent determination, which FDA reaches only after substantive review of the predicate comparison and the performance data.
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Sources & References
- 21 CFR 807.87 - Information Required in a Premarket Notification Submission
- 21 CFR Part 807 Subpart E - Premarket Notification Procedures
- FDA Guidance - Electronic Submission Template for Medical Device 510(k) Submissions
- FDA Guidance - Electronic Submission Template for Medical Device De Novo Requests
- FDA eSTAR Program
