26 September 2017 - Today, the U.S. FDA announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionise digital health regulation in the U.S. 

FDA Commissioner Scott Gottlieb, M.D. announced today the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.

The FDA’s Pre-cert pilot program is intended to inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product. The goal of this new approach is for the FDA to, after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to pre-certify the company. With the information gleaned through the pilot program, the agency hopes to determine the key metrics and performance indicators for pre-certification and identify ways that pre-certified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program. The FDA is also considering, as part of the pilot program, whether and how, pre-certified companies may not have to submit a product for premarket review in some cases.

Read FDA press release