FDA 510(k) Submission

Basic Steps in the Medical Device Premarket Notification Process

  1. Confirm classification of your medical device and whether it falls under the 510(k) pathway.
  2. Using the FDA website, identify the appropriate three-letter product code and regulation number for your device.
  3. Conduct research on the FDA database and select a predicate for comparison.
  4. Search on the FDA website for applicable FDA guidance documents.
  5. Determine which international “consensus standards” may apply to your device.
  6. Identify clinical data and/or testing that may be required for your device.
  7. Complete performance testing and perform clinical studies (if required).
  8. Assemble all documentation into the 510(k) application.
  9. Review the Refuse to Accept (RTA) checklist to ensure that you’re following the FDA guidelines for completeness.
  10. Pay the 510(k) review fee, get the receipt, and then submit the 510(k) to FDA.
  11. Receive confirmation from FDA within 2 weeks that your 510(k) was accepted for substantive review.
  12. If you 510(k) is determined to be substantially equivalent, you will receive a letter and it will be posted on the FDA website and this will serve as proof that your device may be legally marketed in the US. No certificate will be issued.

The official nomenclature for a 510(k) is premarket notification. We should note that FDA does not actually “approve” 510(k) submissions – they “clear” (authorize) a device to be marketed in the US. That’s why a 510(k) is called a premarket notification and not premarket approval (PMA), which applies only to Class III devices. But for the sake of clarity, we use the term approval in this introductory article. The FDA does “approve” Class III medical devices via the PMA process.