How Many Companies Stand to Benefit from the FDA Pre-Cert Program? Fewer Than You Might Think


Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, authored an article in MobiHealthNews, titled “How Many Companies Stand to Benefit from the FDA Pre-Cert Program? Fewer Than You Might Think.”

Following is an excerpt:

In January, FDA released version 1.0 of its Working Model for the agency’s Precertification Program for Software as a Medical Device (SaMD) (i.e. software which functions as a medical device without reliance on hardware). I actually think 1.0 is a bit of a misnomer. It ought to be labeled something like version 0.7, because it’s really about 70 percent of a complete proposal. It lacks many of the details necessary to give an understanding of how it will work.

FDA apparently intends to start filling in the remaining 30 percent during the course of 2019 as it proceeds with the pilot program, involving nine guinea pig companies selected back in 2017, and retrospectively reviews some previously submitted marketing applications for software products. So maybe by the end of 2019 we will see a true version 1.0. Companies beyond those nine will not be allowed to use this program until the pilot is over, presumably in 2020 or after.

While it is too early to fully evaluate the program, FDA has made enough progress since version 0.2 released in June 2018 that parts of it are starting to come into focus. This article summarizes the new developments, and assesses, at least at this juncture, what kinds of companies might find this program valuable in the future.  Spoiler alert: fewer than you might think.