The US Food and Drug Administration has published draft guidance establishing two pathways for medical device manufacturers filing de novo petitions to reclassify their devices from Class III to Class I or II. Up to now, the FDA has characterized the de novo process as underutilized due to process inefficiencies.

Set up to address “new” devices that the FDA has found not substantially equivalent (NSE) during 510(k) reviews, the de novo process enables a manufacturer or sponsor to request that the agency make a risk-based classification decision on its product. A successful de novo petition results in reclassification of the device from Class III to a lower-risk category.

De Novo applicants must meet two criteria: First, the device in question should not fall within a device type that has already been classified based on risk. Second, the device in question must have already been classified as Class III, with written FDA notice, no more than 30 days prior to the de novo petition.

The first pathway for the de novo process is the pre de novo submission (PDS), designed to provide applicants with early-stage access to regulatory reviewers who analyze whether a device is indeed suitable for the de novo process and recommend information to submit with a de novo petition. The PDS pathway, according to the guidance, will provide applicants with greater predictability and transparency during the de novo process. Submission of a PDS would preclude submission of a 510(k) application and de novo petition.

The second pathway entails a standard 510(k) submission, the method currently in place for de novo applicants. Once a 510(k) submission has resulted in an NSE, the applicant has 30 days to submit a de novo petition for a device.