The FDA is seeking test cases from software organizations planning to submit a De Novo Request or 510(k) submission for software as a medical device (SaMD) in 2019 or shortly thereafter to meet the goals of the Test Plan. The FDA’s request for test case submissions follows the rollout of the Pre-Cert program’s test plan earlier in 2019 establishing processes for evaluating safety and effectiveness of SaMD products.
To ensure that the entire Pre-Cert framework is appropriately evaluated, the FDA intends to prioritize selection of premarket submissions (510(k) submissions or De Novo Requests) that will enable evaluation and testing of all four components outlined in version 1.0 of the Working Model. Recognizing the need to test the Pre-Cert model against a diverse set of test cases, the FDA is looking for volunteer cases to represent a broad spectrum of software developers:
Small and large software development firms;
Companies that develop a range of products, including both low- and high-risk SaMD; and
Companies that are not considered to be traditional medical device manufacturers but who intend to make SaMD.
On a rolling basis, FDA plans to select Pre-Cert test-case participants according to following criteria:
The company plans to submit a 510(k) or De Novo Request for a SaMD product prior to June 2020;
The organization volunteering for the test plan and does not have any outstanding FDA compliance issues on record;
The company has an existing track record developing, maintaining and/ or testing software products using processes measured and monitored using key performance indicators;
The company agrees to provide access to key performance indicators; collect real-word post-market performance data; available for real-time consultations with and Excellence Appraisal site visits from FDA; and provide quality management system data;
The company provides dates that it expects to be ready and willing to participate in an Excellence Appraisal and participates in the planning of the Excellence Appraisal site visit in 2019.
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