The test phase of FDA’s Software Precertification (Pre-Cert) Program has hit its halfway point. The agency has released an update on its progress and the lessons it has learned to date. The program aims to “reimagine” how FDA regulates digital health devices, specifically software as a medical device (SaMD). This test phase is designed to confirm that the framework will provide reasonable assurance of safety and effectiveness for software products that is equivalent to FDA’s traditional review pathway.

FDA has completed its “retrospective testing,” which was intended to determine whether a premarket regulatory decision could be made based on an “excellence appraisal” summary and “streamlined review” elements.

And the determination is yes. FDA says that reviewers conducting the mock review generally reported that a regulatory decision could be made using the information acquired from the these elements. However, the test team, including the reviewers, identified opportunities to simplify the process for sponsors and reviewers. The test team recommended that elements of the submission identified in the working model be in a structured format for submissions to be included in the prospective testing.

To better structure the information for review determination, the team developed SaMD product-level elements using cleared or approved SaMDs. According to FDA, the team sought to identify specific questions for future use by precertified organizations. These provided the appropriate content and level of information needed on the SaMD ­product-­level elements that may support streamlined review and transparency to the public. Re­viewers used the sample SaMD product-level elements to test whether they could support streamlined review and whether they could be used to determine the SaMD risk category.

And here, they got more good news. Although the working model estimated that the excellence appraisal would be completed in five business days, the actual process was completed in only three to four business days during prospective testing.

According to FDA, the test achieved its objectives in identifying the feasibility of the streamlined review package and excellence appraisal summary to be a sufficient method for conducting a premarket review of an SaMD.

Applying a collaborative, capability-based approach for the appraisal, says the agency, creates an open and transparent evaluation that identifies organizational strengths and appropriate strategies for driving opportunities for im­provement. FDA does note, however, that some of the elements may need to be separated or removed to improve clarity as the program continues to develop. If the next test phase goes as well, OEMs will soon have a faster, more streamlined path for SaMD approvals.

Sherrie Trigg

Editor and Director of Medical Content

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