Refuse to Accept (RTA) is FDA's administrative review of 510(k) submissions to determine whether they meet a minimum threshold of acceptability for substantive review based on a checklist. FDA applies its Refuse to Accept checklist within the first 15 calendar days of receiving a 510(k), checking that required elements such as device description, comparison to the predicate, labeling and performance data are present. It is an administrative completeness check, not a scientific review. The eSTAR template, mandatory for most 510(k)s since October 2023, builds many of these checks into the form and largely replaces the separate RTA screen for those submissions.

Why it matters

RTA decisions occur in the first 15 calendar days of the review clock. If FDA finds missing checklist items, the submission is held (RTA hold) and the 90-day review clock stops until the sponsor submits the missing content. Two consecutive RTA holds can effectively add 60 to 120 days to the timeline. Similar acceptance reviews exist for De Novo (Acceptance Review) and PMA (Filing Review). The most common RTA triggers in 2024-2025 have shifted from labeling and administrative gaps to cybersecurity content: missing SBOM, no threat model, no vulnerability management plan, no coordinated disclosure policy under Section 524B.

Common pitfalls

•Ignoring the eCopy or eSTAR technical validation errors before submission. Technical failures cause immediate RTA.
•Treating cybersecurity content as optional for 510(k). Under 524B, any cyber device submission without SBOM, CVD policy, and vulnerability management triggers RTA.
•Inconsistent indications-for-use wording across the cover letter, Section 4, and labeling. This is the single most common non-cyber RTA reason.
•Submitting near a quarter-end deadline without a full internal RTA checklist review. FDA follows the checklist strictly; sponsors should too.

Sources

FDA 510(k) RTA Policy (final guidance) · FDA
Acceptance Review for De Novo Classification Requests · FDA
RAPS Regulatory Focus · RAPS

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MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.