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510(k) Resources, Checklists, Templates & FAQs

510(k) Resources and Frequently Asked Questions

Effective 510(k) preparation uses FDA databases, checklists, standards, and guidance documents to ensure completeness and compliance. Leveraging these tools and the pre-submission program streamlines review and reduces regulatory risk.

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Successful 510(k) preparation relies on understanding and utilizing authoritative resources. This page compiles key tools, templates and answers to common questions. 

Key resources

  • FDA Product Classification Database
    Search this database to identify regulation numbers, product codes, device classes and exemption status for your device.
  • FDA 510(k) database
    Review summaries of cleared devices similar to yours. These summaries often include test methods and predicate comparisons that can inform your strategy.
  • eSTAR template and eCopy guidance
    The FDA’s interactive eSTAR template ensures all required sections are addressed, while the eCopy guidance explains file formatting and labeling requirements.
  • Refuse to Accept (RTA) checklists
    Use the RTA checklists for traditional, special and abbreviated 510(k)s to verify your submission is complete.
  • Recognized consensus standards
    Consult standards such as ISO 14971 for risk management, ISO 10993 for biocompatibility, IEC 60601‑1 for electrical safety and IEC 62304 for software lifecycle processes. Declare conformity where applicable and provide test reports.
  • FDA guidance documents
    Guidance documents clarify what information the FDA expects for specific device types, technologies or submission formats (e.g., biocompatibility guidance, software guidance, cybersecurity guidance).
  • Pre‑submission program
    The Q‑Submission program allows you to obtain FDA feedback on classification, predicate selection and test plans.

Frequently asked questions

What is a 510(k) and who must submit? A 510(k) is a premarket notification demonstrating that a device is substantially equivalent to a predicate. U.S. manufacturers, specification developers and importers must submit a 510(k) when introducing a new device or making significant modifications.
How long does the 510(k) review take? The FDA aims to complete the review within 90 FDA days. Including preparation and responses to AI requests, the overall process often takes about 125 days.
What if there is no predicate for my device? If no predicate exists and your device is low to moderate risk, you may pursue the De Novo pathway. If the device is high risk, a PMA is required.
Are there fee reductions? mall businesses with less than $100 million in annual revenue may qualify for reduced 510(k) fees. Third‑party reviewed 510(k)s have no FDA fee.
Do I have to address observations not listed in a Form 483? Yes. Investigators may not list every objectionable condition; companies are expected to correct both cited and non‑cited issues.

Using these resources and understanding these FAQs will help you prepare a complete and compliant 510(k). If questions remain, engage regulatory experts or request a pre‑submission meeting for guidance. 

For additional questions, contact us for a consultation.

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