--- title: "RTA, Refuse to Accept | MedTech Terms" description: "FDA administrative decision that a submission is incomplete and won't be substantively reviewed. 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Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition 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. What the regulation says The FDA conducts a Refuse to Accept (RTA) review for 510(k) submissions, as outlined in "Refuse to Accept Policy for [510(k)](/terms/510k)s - Guidance for Industry and Food and Drug Administration Staff." This initial administrative assessment determines if a submission is complete enough to proceed to a substantive review, examining whether it meets basic requirements rather than evaluating scientific merit. Similarly, the FDA also applies RTA principles to [De Novo](/terms/de-novo) and [PMA](/terms/pma) submissions, each with specific guidance documents detailing the acceptance criteria. ## What this means in practice 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](/terms/de-novo) (Acceptance Review) and [PMA](/terms/pma) (Filing Review). The most common RTA triggers in 2024-2025 have shifted from [labeling](/terms/labeling) and administrative gaps to cybersecurity content: missing [SBOM](/terms/sbom), no threat model, no vulnerability management plan, no coordinated disclosure policy under Section [524B](/terms/section-524b). ## Examples - A connected wearable 510(k) is held RTA on day 12 because the SBOM only lists top-level components without transitive dependencies, and no CVD policy is documented. - A traditional Class II 510(k) is held RTA because the indications for use statement in Section 4 does not match the labeling in Section 12. 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. ## Frequently asked questions How long does an RTA review take? FDA completes the RTA review within 15 calendar days of receipt. If accepted, the substantive review clock starts on day 16. If held, the clock stops until the sponsor submits the missing content, at which point a new 15-day RTA cycle begins on the corrections. What are the most common RTA reasons in 2025? Do De Novo and PMA have an equivalent to RTA? Can I appeal an RTA decision? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory De Novo Classification Request(De Novo) Pathway to classify novel low- to moderate-risk devices that lack a predicate. ](/terms/de-novo)[ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Cybersecurity Premarket Cybersecurity Submission The bundle of cybersecurity artifacts a sponsor includes in a 510(k), De Novo, PMA, or HDE submission for a cyber device. ](/terms/premarket-cybersecurity)[ Cybersecurity Section 524B of the FD&C Act(524B) The federal statute that gives FDA explicit premarket authority over cybersecurity for cyber devices. ](/terms/section-524b) ### FDA Cybersecurity 101 · From this learning path [ Cybersecurity Common Vulnerability Scoring System(CVSS) An industry-standard 0–10 score that quantifies the severity of a software vulnerability. Adjacent lesson ](/terms/cvss?from=fda-cybersecurity-101)[ Cybersecurity Common Vulnerabilities and Exposures(CVE) A globally unique identifier for a publicly disclosed cybersecurity vulnerability. ](/terms/cve?from=fda-cybersecurity-101)[ Cybersecurity CycloneDX A lightweight, OWASP-maintained SBOM format designed for application security and supply-chain use cases. ](/terms/cyclonedx?from=fda-cybersecurity-101)[ Cybersecurity Secure Product Development Framework(SPDF) A documented, risk-based set of processes that build cybersecurity into a medical device across its full lifecycle. ](/terms/spdf?from=fda-cybersecurity-101) ### 510(k) Fundamentals · From this learning path [ Regulatory Indications for Use(IFU (statement)) Description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate. Adjacent lesson ](/terms/indications-for-use?from=510k-fundamentals)[ Regulatory Intended Use The objective intent of the manufacturer regarding the use of the device. ](/terms/intended-use?from=510k-fundamentals)[ Regulatory Predicate Device A legally marketed device used as the comparator in a 510(k) submission. ](/terms/predicate-device?from=510k-fundamentals)[ Regulatory Substantial Equivalence(SE) The legal standard a 510(k) device must meet versus a predicate. ](/terms/substantial-equivalence?from=510k-fundamentals) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [FDA Cybersecurity 101](/paths/fda-cybersecurity-101)Lesson 11 of 11 - [510(k) Fundamentals](/paths/510k-fundamentals)Lesson 6 of 7 Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 FDA· 2 RAPS· 1 1. [1 FDA 510(k) RTA Policy (final guidance) Verified FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks) 2. [2 Acceptance Review for De Novo Classification Requests Unchecked FDA · fda.gov ](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptance-review-de-novo-classification-requests) 3. [3 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Acronym RTA Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=rta) Learn in 60 seconds Card Lesson Quiz FDA administrative decision that a submission is incomplete and won't be substantively reviewed. - · 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. Remember this Watch out: Ignoring the eCopy or eSTAR technical validation errors before submission. Technical failures cause immediate RTA. Related terms - [510(k) Premarket Notification(510(k)) ](/terms/510k) - [De Novo Classification Request(De Novo) ](/terms/de-novo) - [Premarket Approval(PMA) ](/terms/pma) - [Premarket Cybersecurity Submission ](/terms/premarket-cybersecurity) - [Section 524B of the FD&C Act(524B) ](/terms/section-524b) - [eSTAR ](/terms/estar) You may also need Auto-suggested from Regulatory and shared keywords. - [Refuse to Accept (Cybersecurity)(RTA (cyber)) ](/terms/rta-cyber) - [Modular PMA ](/terms/pma-modular) - [510(k) Summary vs 510(k) Statement ](/terms/510k-summary-vs-statement) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [Breakthrough Device Designation(BDD) ](/terms/breakthrough-device) - [513(g) Request for Information(513(g)) ](/terms/513g) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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