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. 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, M.D., 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.
Gottlieb thinks this will encourage digital health innovation while protecting patients. But his team needs to gather information before the program is ready for primetime. To do this, participants in the pilot project will show the FDA the measures they use to develop, test and maintain software and welcome agency staff to their sites to discuss their quality management systems. The ways companies collect postmarket reports are of particular interest to the FDA given this data will be critical to safety in a environment with reduced upfront regulatory requirements.
If the scheme takes off, it could close the gap between timelines involved in developing consumer technologies—where frequent updates are the norm—and approving medical devices. This gap is a sticking point for some tech giants. Google co-founder and Alphabet President Sergey Brin called device regulation “painful” in explaining why his company would partner off its products. And Apple CEO Tim Cook has explicitly cited FDA cycle times as a problem.
“We don’t want to put the Watch through the [FDA] process. It would hold us back from innovating too much, the cycles are too long,” Cook said in 2015.
The pilot program’s focus on software means regulatory cycle times for the Apple Watch and other hardware will remain a barrier for some companies for the foreseeable future. But the FDA pilot program creates the opportunity for companies to innovate quickly through updates to the apps and other software that run on their hardware.