FDA soliciting new volunteers to test drive its experimental Pre-Cert Program

Companies planning an upcoming De Novo or 510(k) submission for their software medical device are eligible, but participation will not yield precertification.
By Dave Muoio
03:07 pm

The FDA has put out a call for new companies to test drive the current framework of its Digital Health Software Precertification Program, the ongoing effort to streamline regulation of digital health products prone to frequent update.

Organizations that are expecting to sponsor either a 510(k) submission or De Novo Request for a software as a medical device (SaMD) during 2019 or early 2020 are eligible to volunteer, although the agency wrote in its notice that it doesn’t plan to award precertification to those that complete the test process.

“To ensure that the entire Pre-Cert framework is appropriately evaluated, the FDA intends to prioritize selection of premarket submissions … that will enable evaluation and testing of all four components outlined in version 1.0 of the Working Model,” the agency wrote in its notice.

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“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.”

Companies that have submitted a statement of interest to the FDA will receive notice of their acceptance on a rolling basis, the agency wrote. Hopefuls will be considered based on the timing of their premarket submission, good standing, track record and ability to comply with the requirements of the Working Model.


The FDA’s decision to solicit new volunteers is a stark departure from the program’s original game plan, as the agency had initially selected just nine companies to participate in the Pre-Cert pilot back in 2017. What’s more, the program was previously limiting its test cases to De Novo submission, but now appears to be open to 510(k)s as well.

“As recently as January, FDA said that its plan was to limit this to those submitting De Novo's, and that they would proceed along the two different regulatory paths simultaneously,” Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in consulting with digital health startups about FDA clearance, told MobiHealthNews in an email commentary.

“This is important because they do not have legal authority for this program from Congress.  So if they are now going to open it up to companies pursuing 510(k)'s, I assume — but don't know — that they’re planning to do a parallel 510(k) review process along with the precertification program.”

With this in mind, Thompson questioned why companies already facing the hurdles of a normal regulatory submission would be interested in acting as guinea pigs for the Test Plan — especially if their time and effort cannot yet be rewarded with precertification.

“I imagine that some companies will want to get in on the ground floor the program, gaining experience early on. But obviously that only makes sense if you believe this program will ever come to fruition. Given the extraordinarily slow pace of and little progress in developing the program over the last couple of years, and the fact that they will need legislative authority, the future the program is quite uncertain,” he wrote. “What is certain is the burdens of participating. If a company is planning to pursue a 510(k), then in order to participate in this program, all of a sudden they have to go through a full body cavity search for the excellence appraisal, including visits from FDA, as well as agree to all sorts of additional burdens such as collecting and providing real-world postmarket performance data.”


Since kicking off in 2017, much of the agency’s work on the Pre-Cert Program has taken place behind closed doors with Apple, Fitbit, Verily, Tidepool and other early participants. Some of the agency’s early drafts of a working model caught flak from industry observers and legislative leaders alike (although a healthy share of MobiHealthNews readers said they were optimistic about the program’s potential). January’s release of a Test Plan and Working Model are among the most recent updates to the agency’s experimental effort, and will be the guidelines by which new volunteers for the program will have to abide.


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