FDA Seeks SaMD PreCert Mock Applicants

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 Pre...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Standards & Regulatory Source Type: blogs