In January 2019, in conjunction with Version 1.0 of its Working Model for the Software Precertification Program, FDA issued a 2019 Test Plan for testing the software precertification model before employing it as a full-scale alternative premarket pathway for software as a medical device (“SaMD”) products. The primary purpose of the Test Plan is to assess whether the Excellence Appraisal process and Streamlined Review components of the precertification program, as described in the Working Model, together produce an equivalent basis for determining reasonable assurance of safety and effectiveness for SaMD products.
The Test Plan will consist of retrospective and prospective testing on a series of test cases. For retrospective testing, FDA will extract elements that are proposed to be included in a Streamlined Review from a previously-reviewed, complete submission package for a SaMD product. FDA will review this set of product-specific data then determine what additional information not supplied by the Streamlined Review package would be needed to determine an assurance of safety and effectiveness. FDA will then review the proposed Excellence Appraisal elements to confirm that, if an Excellence Appraisal had been conducted, the questions remaining for the review of the product would be answered during an Excellence Appraisal.
For prospective testing, FDA intends to use a mock Streamlined Review package for a group of selected premarket submissions. Specifically, FDA will conduct an Excellence Appraisal with the sponsor, but require the sponsor to also submit traditional marketing submissions. FDA staff would assemble a mock Streamlined Review package and an independent review team would then evaluate whether it can determine sufficient information from the Excellence Appraisal elements to provide an assurance of safety and effectiveness. If the review team finds gaps in evidence in the mock Streamlined Review package, the team would request unmasking of specific elements from the full submission. FDA envisions the prospective testing to be an iterative process.
At the conclusion of the 2019 Test Plan, FDA intends to have demonstrated that the totality of evidence collected through the Excellence Appraisal and Streamlined Review processes align to and satisfy the regulatory requirements for making a determination of reasonable assurance of safety and effectiveness.
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