Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review

What You Need to Know? 👇

What is the purpose of the FDA’s Refuse to Accept (RTA) policy for 510(k) submissions?

The RTA policy ensures 510(k) submissions meet minimum administrative completeness before substantive review begins. This focuses FDA resources on complete submissions, improving efficiency and helping safe, effective medical devices reach patients faster.

How long does FDA have to complete the acceptance review for a 510(k) submission?

FDA must complete the acceptance review within 15 calendar days of receiving the submission. If the review isn’t completed within this timeframe, the submission automatically proceeds to substantive review.

What happens if my 510(k) submission receives an RTA designation?

You’ll receive electronic notification with a completed checklist identifying missing elements. You can respond by providing the missing information under the original 510(k) number without paying new fees or resubmitting the entire application.

Can I submit an Abbreviated 510(k) if I rely on FDA-recognized consensus standards?

Yes, if you rely on FDA-recognized consensus standards and include a Declaration of Conformity or demonstrate general use with supporting data, your submission may qualify for the Abbreviated 510(k) pathway.

What’s the difference between acceptance review and substantive review in the 510(k) process?

Acceptance review assesses administrative completeness using objective criteria, while substantive review evaluates data quality and makes substantial equivalence determinations. Only presence of information matters for acceptance, not adequacy.

When does the FDA review clock start for MDUFA performance goals?

The review clock starts on the Document Control Center receipt date of the submission that results in acceptance, provided user fees are paid and a valid eCopy is received.

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What You Need to Do 👇

Recommended Actions

1. Review submission type criteria to determine appropriate 510(k) pathway (Traditional, Abbreviated, Special)
2. Complete applicable RTA checklist during submission preparation to ensure all required elements are included
3. Provide clear rationale for any checklist items deemed not applicable
4. Include acceptance checklist with submission identifying location of required information
5. Highlight or prominently identify any changes in proposed labeling
6. Ensure design control activities summary addresses all required elements for Special 510(k)s
7. Submit complete test reports or declarations of conformity for any performance testing
8. Provide clear substantial equivalence discussion comparing subject and predicate devices
9. Include signed statements regarding design control compliance for Special 510(k)s
10. Address any applicable device-specific guidance documents, special controls, or classification requirements

Key Considerations

Clinical testing

• Must include completed Financial Certification/Disclosure forms for covered clinical studies
• Must include ClinicalTrials.gov certification for applicable device trials
• Must include statements of compliance with 21 CFR parts 50, 56, and 812 for US studies
• Must include GCP compliance statements for OUS studies

Non-clinical testing

• Must include summaries and full test reports of non-clinical laboratory studies
• Must include explanation of how data supports substantial equivalence
• For animal studies, must include protocol, final report and GLP compliance statement

Labeling

• Must include proposed package labels and labeling (IFU, package insert, etc.)
• Must include indications for use statement identical to 510(k) Summary
• Must include adequate directions for use and warnings/precautions
• Must include manufacturer name and address
• Must include Rx statement if prescription device

Software

• Must state software level of concern and rationale
• Must provide documentation based on level of concern per FDA guidance

Cybersecurity

• Must identify if device has external interfaces
• Must provide documentation per FDA cybersecurity guidance if applicable

Biocompatibility

• Must identify tissue-contacting components and materials
• Must identify contact classification for each component
• Must address relevant biocompatibility endpoints through testing or rationale

Safety

• Must include electrical safety evaluation if applicable
• Must include EMC evaluation if applicable
• Must include sterilization information if provided sterile
• Must include shelf life/stability data if applicable

Other considerations

• Must be in English
• Must identify device name, classification, and predicate
• Must include substantial equivalence discussion
• Must include design control activities summary for Special 510(k)s

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Relevant Guidances 🔗

• Content of Premarket Submissions for Device Software Functions
• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
• Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
• Design Controls for Medical Device Manufacturers

Related references and norms 📂

• IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
• ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

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Original guidance

• Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
• HTML / PDF
• Issue date: 2022-04-21
• Last changed date: 2022-04-25
• Status: FINAL
• Official FDA topics: Medical Devices, 510(k), Premarket, Biologics, Administrative / Procedural
• ReguVirta ID: 425afef65eba97e1fdd4e47a0e733b66