FDA’s Software Pre-Certification (Pre-Cert) Program is intended to create a new streamlined regulatory process for software as a medical device (SaMD) (see our earlier blog posts on the program here, here, here, and here). In January of this year, FDA released version 1.0 of Developing a Software Precertification Program: A Working Model (Working Model) and an accompanying Software Precertification Program: 2019 Test Plan (Test Plan). On May 21, 2019 the Agency announced in the Digital Health Software Precertification (Pre-Cert) Program: Participate in the 2019 Test Plan (Announcement) that it now is seeking test cases for prospective testing of the Pre-Cert Program.
For testing, FDA is looking for software organizations of all sizes that plan to submit a De Novo Request or 510(k) for their SaMD in 2019 or shortly thereafter. They also are looking for software developers that develop both low- and high-risk SaMDs as well as those that intend to develop a SaMD but are not considered a traditional medical device manufacturer. Participants should not have any outstanding FDA compliance actions and should have an “existing track record in developing, testing, and maintaining software products demonstrating a culture of quality and organizational excellence measured and tracked by key performance indicators or other similar measures.” Announcement at 2. In our review of the initial Test Plan, issued in January 2019, it was not clear whether only those companies pre-certified as part of the pilot program would be eligible to participate. The current Announcement clarifies that non-pilot companies can participate in this phase of testing.
The Pre-Cert program, as outlined in the Working Model, has four key components following a Total Product Lifecycle (TPLC) approach:
- Demonstrate a culture of quality and organizational excellence through an Excellence Appraisal (pre-certification).
- Determine the SaMD’s required review through Review Determination.
- Conduct a Streamlined Review, and
- Verify a SaMD’s continued safety, effectiveness and performance and the organization’s commitment to culture of quality through post-market Real-World Performance.
As part of the testing, participants must be willing to undergo evaluation for all four components of the TPLC approach, but their submission’s review will not be streamlined. FDA will conduct an Excellence Appraisal of the participating organization as part of the testing. However, they do not intend to provide any new precertifications during the testing phase and there is no information regarding whether the Excellence Appraisal might be used in the future, after completion of the Pre-Cert pilot and testing phase. In addition to undergoing an Excellence Appraisal, participating companies must provide access to their unique key performance indicators that are used to monitor internal processes, collect real-world postmarket performance data and make it available to FDA, be available for consultation with FDA and provide information on the company’s quality management system. This is all in addition to preparing and submitting the De Novo Request or 510(k) submission and undergoing a standard review. Other than stating that the testing will occur in 2019, the Announcement does not provide clarity in whether these activities will take place before, during or after review of the marketing application or discuss how long these activities, especially review of postmarket performance data, might last.
Although the Announcement does not describe any potential benefit to participants to offset the additional company time and resources needed for the Excellence Appraisal and additional FDA interactions, testing this new model’s ability to achieve an equivalent basis for SaMD product evaluation is important so we hope some companies will consider it. If the program is successful, participating companies could see future benefits of shortened review times. However, given what appear to be significant efforts to participate, we remain concerned that there may not be enough volunteered submissions to adequately validate the program. For those companies that meet the criteria and want to participate, a statement of interest should be submitted to FDAPre-CertPilot@fda.hhs.gov.