Medical DevicesLast reviewed April 2026

Refuse to Accept(RTA)

FDA's decision not to accept a 510(k) submission for substantive review due to administrative or completeness deficiencies.

Usage Examples

FDA issued an RTA citing three missing attachments and an incomplete substantial equivalence table.
The team ran a final RTA checklist review before submission to minimize preventable deficiencies.
Resubmission after an RTA restarted the 90-day review clock.

What is RTA?

A Refuse to Accept (RTA) is FDA's determination that a 510(k) or De Novo submission cannot be accepted for substantive review because it is administratively or operationally incomplete. FDA must complete acceptance review within 15 calendar days of submission receipt. An RTA notice lists the specific deficiencies the sponsor must address, and the review clock stops until an acceptable resubmission is received.

RTA is not a scientific rejection. It addresses items on FDA's Acceptance Review Checklist: required administrative content, predicate information, substantial equivalence comparison structure, required performance testing sections, labeling, and eSTAR template completeness. An RTA can add 30-90 days to clearance timeline depending on how quickly the sponsor resubmits.

Common RTA triggers include missing required eSTAR sections, unresolvable cross-references within the submission, inadequate predicate identification, and missing attachments FDA expects based on the device's product code and risk profile. Strong pre-submission validation and content-level completeness checks reduce RTA risk significantly.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 807, FDCA SECTION 510K.

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When This Matters

FDA issued an RTA citing three missing attachments and an incomplete substantial equivalence table.
The team ran a final RTA checklist review before submission to minimize preventable deficiencies.
Resubmission after an RTA restarted the 90-day review clock.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 807FDCA SECTION 510K

Frequently Asked Questions

No. An RTA is an acceptance-level determination based on completeness and administrative criteria, not a scientific rejection. The submission can be corrected and resubmitted. A scientific rejection happens during substantive review through a Not Substantially Equivalent decision.

Remediation time depends entirely on the nature of the deficiencies. Missing administrative content can be fixed in days; a fundamentally incomplete predicate analysis may take weeks to strengthen. FDA starts a fresh 15-day acceptance review on resubmission.

Run FDA's Acceptance Review Checklist against the draft submission before filing. Ensure eSTAR is structurally complete, required attachments for the device type are included, and the predicate comparison table addresses all intended-use, technological-characteristic, and performance-data dimensions.