The Food and Drug Administration has chosen Fitbit, Apple, Samsung and Alphabet’s life sciences unit Verily to participate in a trial program. It intends that the program will give allowance for the various companies to skip certain regulations to expedite innovation.
A large number of companies will be in a position to pre-clear the complex approval processes as well as the typical months-long standard applications. The program will be crucial towards enabling most of the companies to introduce their products to the market much quicker. Most of these providers deeply invested in the development of new digital health technology devices and apps.
Both Fitbit and Apple have in the recent years tackled the widespread medical conditions through their wearables. Cupertino-based Apple is collaborating with the Stanford School of Medicine. By the end they hope to succeed in offering a solution to assist in the detection of abnormalities in the heart’s rhythm. On the other hand, the San Francisco-based Fitbit has involved itself in seeking out solutions to assist in the detection of sleep apnea.
FDA Commissioner Dr. Scott Gottlieb on Tuesday attended a Conference in San Jose where he announced the program.
He opined, “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate. These pilot participants will help the agency shape a better approach toward digital health technology that focuses on the software developer.”
Through the pilot program, the FDA is looking forward to collecting information from the provider’s about performance indicators for precertification. With well designed criteria in the future, precertified providers may soon be in a position to submit less information to the FDA than is currently required for approval.
Journalists tried reaching out to the Apple in the hope that it would make its comments in relation to the matter. Unfortunately, it did not give an immediate response. Fitbit CEO James Park resorted to Twitter in celebrating his company making the cut. A lot of the interested parties will be watching closely to see the progress the companies make.