FDA Announces New Pre-Certification Pilot Program for Software

By: Ashley Sloat, Ph.D.

Many of our clients are in the digital health space, so here is a brief update on new developments in FDA regulation of this space. The new FDA Commissioner Scott Gottlieb, M.D. announced last week that the FDA is formally launching a voluntary Pre-Cert for Software Pilot Program. Scott Gottlieb states that: “This new program embraces the principle that digital health technologies can have significant benefits to patients’ lives and to our healthcare system by facilitating prevention, treatment, and diagnosis; and by helping consumers manage chronic conditions outside of traditional healthcare settings.” 
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The polite program will work similar to TSA pre-check in that companies that have a demonstrated track record of software quality (based on design, validation, and maintenance) will experience an expedited approval route through the FDA (e.g., required to submit less or no information prior to marketing the new tool). In contrast, those companies that require more quality assurance will be required to submit more information before marketing their new digital health tool. A link to the press release from the FDA is here. If you are a company in the digital health space, I encourage you to investigate whether you have any interest in volunteering to be a part of this polite program. We all know that more regulation is coming to the digital health space, now each of us has to determine if we want to contribute to the shape of that regulation.