Commentary: Why FDA’s Software Precertification Program May Be Bad for Business


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 “Commentary: Why FDA’s Software Precertification Program May Be Bad for Business.”

Following is an excerpt:

FDA’s concept of a precertification program for software has certainly caught the attention of senior management at many companies. I’m hearing stories of unbridled enthusiasm for the idea. I describe it as a “concept” because, of course, it hasn’t been created yet. A year and a half after floating the idea and more than a year since the formal, public drafting process began, FDA has only circulated very high level concept papers.

As companies wait for more details, for several reasons they need to be just a little bit cynical about what they’re hearing, and become more active in trying to shape what the program ultimately turns out to be in some very key dimensions that could make or break the program.

Related reading:

MobiHealthNews, "Poll: Is the FDA Pre-Cert Program an Effective Way to Regulate Digital Health Products?"