fda-510k-pathway

First classify the device as Class I, II, or III. Most Class I and some Class II devices are 510(k)-exempt and only need establishment registration and listing, while all Class III devices require PMA. Non-exempt Class I/II devices must submit a 510(k).

Traditional is the standard 90-FDA-day path with full substantial equivalence evidence. Abbreviated relies on FDA-recognized consensus standards to reduce testing documentation. Special applies only to design changes to your own cleared device and reviews in about 30 days.

Search the FDA 510(k) Premarket Notification Database and Product Classification Database by product code, prioritizing devices cleared within the last five years. Review candidate 510(k) Summaries for indications for use, and designate one primary predicate in your submission.

Yes if it contains software or firmware, programmable logic, or any connectivity including USB ports, Bluetooth, or dormant wireless modules. The submission must include threat modeling, an SBOM, vulnerability management, coordinated disclosure, security risk management, testing evidence, and update plans.

About 30% of first submissions fail the Refuse to Accept administrative review. Frequent causes include listing multiple predicates without a primary, missing declarations of conformity for electrical testing, absent SBOMs, incomplete translations, and unclear substantial equivalence comparison baselines.

Use a PCCP when your AI/ML device will undergo continuous learning or frequent updates. It adds three modules describing planned modifications, the change protocol, and impact assessment, and is only available through Traditional or Abbreviated 510(k), not Special.