FDA has issued a request for SaMD developers to try out the PreCert excellence appraisal process. Since this is a test program the FDA does not intend to actually provide precertification for participating companies. Criteria for those choosing to participate include:
- Have a plan to submit a De Novo Request or 510(k) submission for a SaMD product prior to June 2020.
- Be in good standing with the FDA.
- Agree to follow aspects of the FDA's working model including providing access to certain key performance indicators, collecting real-world postmarket performance data and make it available to the FDA, be available for real-time consultations with the FDA, be available for Excellence Appraisal site visits from the FDA, and provide information about the firm's quality management system.
Participants may be small or large, currently or not currently considered traditional medical device manufacturers, and having or planning a range of products, including both low- and high-risk SaMD. The inclusion of high risk SaMd here is interesting in that prior discussions of PreCert have limited the program to no more than moderate risk. Yet this test is limited to devices that are not above a 510(k) or De Novo risk level which would seem to exclude high-risk. It is not clear what the inclusion of high- risk here means with respect to plans for the program. Possibly the idea is for a manufacturer already in the high-risk business to show that its existing excellence level would support PreCert for other products. Another issue is how a start-up venture without a product would be in a position to collect performance data.
There are various reasons for a manufacturer to participate including a desire to help the FDA move PreCert along, earning good will with the FDA toward future endeavors, getting an excellence assessment before it really matters, and getting other useful feedback from FDA. Cons include the time and effort involved, and the possibility of a black mark with the FDA that could make future encounters more difficult. It is also possible that one might get burdensome advice that would set future expectations above where they might otherwise be.