A little over six months after the FDA moved its PreCert pilot along to the Test Plan phase, the agency released its Mid-Year Update on the program. At this stage, the original nine FDA PreCert pilot companies are now in the midst of test-driving the new Working Model. This means companies seeking to approve new products will go through the new PreCert pathway and the traditional review process.
The basic goal of the PreCert program, which sets it apart from previous FDA regulatory ventures, is that it will focus not on particular products but on firms and developers. If the FDA is satisfied that the firm is responsible and safe in its development, then it won't need to regulate each product from that firm.
To date, the agency reports that its retrospective testing is complete and its prospective testing is in progress.
As part of the retrospective testing, the agency developed a mock excellence appraisal summary based on the pilot participant site visits and public comments. The agency also created a Streamlined Review package out of elements of the original submissions. Reviewers then did a mock assessment to determine if a regulatory decision could be made on the Excellence Appraisal summary and Streamlined Review elements.
“The test achieved its objectives in identifying the feasibility of the Streamlined Review package along with the Excellence Appraisal summary to be sufficient to conduct a premarket review of SaMD [software as a medical device],” the update reads.
In terms of prospective testing, the agency said it “continues to work with pilot participants and other interested stakeholders who have volunteered for the 2019 testing to conduct an Excellence Appraisal and, in some cases, to test Pre-Cert program components through the review of a De Novo request or 510(k) submission (the FDA will also conduct traditional review for all test cases).”
In May, the agency put out a call for new companies to try out the current framework of its Digital Health Software Precertification Program, the ongoing effort to streamline regulation of digital health products prone to frequent update.
This update has been met with some skepticism among players in the field.
“To be clear, while the materials seem to claim that they are scientific studies of administrative processes, it appears what FDA is really doing is simply testing administrative procedures to make sure that they are feasible,” Bradley Merrill Thompson, an attorney specializing in FDA law, wrote in an email to MobiHealthNews. “The retrospective testing, for example, is all about feasibility. What I find interesting is that FDA’s description of how it conducted this retrospective testing is basically to take the same information that has historically been submitted, and repackage it for review under the precertification program. That suggest that there’s really fundamentally nothing different about precert: it’s looking at the same information only packaged differently and reviewed over three different reviews — the Excellence Appraisal, the Review Pathway Determination and the Streamlined Review — with the added feature that real-world performance will also be evaluated in the future.”
However, there are varying view points on this issue. For example, CEO and President of Pear Therapeutics Dr. Corey McCann, whose company is in the pilot program, recently discussed the benefits of PreCert.
"First and foremost, I would just say it’s a really positive thing for the FDA to be so proactively involved in the evolution of this space,” McCann told MobiHealthNews. “This really fits within the same paradigm that we were already executing, but I think it helps to formalize that paradigm. So if one is to create a prescription digital therapeutic, really you’re concerned with a number of things: two of which are quality and the demonstration of safety and efficacy. ... Here, I think that the PreCert program is going to be very useful in helping us to demonstrate the quality of our processes, and then that quality demonstration will be married with discrete clinical trials demonstrating safety and efficacy for each of our products going forward."
WHY IT MATTERS
If the Pre-Cert program goes through, this could change the way that digital health companies get their products approved and cleared for the future — an especially important shift when considering the frequent updates developers often apply to apps and other software.
THE LARGER TREND
The FDA outlined and adopted its Working Model in January, while mid-May saw an update from the agency seeking new companies to test drive the framework and expanding the requirements from De Novo applications alone to 510(k)s.
Companies that are part of the PreCert pilot are also starting to see progress. Last week prescription digital therapeutics company Pear Therapeutics announced that it was the first to file an FDA marketing authorization through the new framework.