Apple, Johnson & Johnson and a clutch of other big-name tech and device companies have joined a FDA program to fast-track digital health apps, according to a report in FierchBiotech. The pilot program will offer precertified companies an abbreviated regulatory path to market, freeing them from the lengthy cycle times faced by apps classed as medical devices today.
FDA Commissioner Scott Gottlieb, MD, has attracted some of the biggest companies on Earth to the pilot scheme. Apple and J&J are joined by Roche, Samsung and Alphabet’s Verily. Fitbit, Pear Therapeutics, Phosphorus and Tidepool also made the cut.
The companies will work with the agency to shape the precertification program Gottlieb unveiled earlier this year. Through the scheme, the FDA will assess a company’s software design, validation and maintenance before deciding whether to grant it precertification. Companies with precertification will only have to file slimmed-down submissions, or in some cases no application at all, before introducing a digital health tool.