The U.S. Food and Drug Administration said Tuesday it chose nine companies, including the Samsung Group, to participate in its pilot program aimed to streamline digital health regulation.
The FDA Pre-cert pilot program, launched on July 27, addresses the problem of slow review processes in healthcare, especially of digital health technology. In July, the regulatory body said the program is determining the best method to regulate non-traditional medical tools.
“FDA’s traditional approach to medical devices is not well suited to these products. We need to make sure our approach to innovative products is efficient and fosters, not impede innovation,” FDA Commissioner Scott Gottlieb said. “Our new, voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the developer rather than the product.”
As part of the FDA’s Digital Health Innovation Action Plan, the program will look at the company, rather than the company’s product, to determine whether its products are safe and efficient.
The other eight selected companies are Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Tidepool, and Verily, the agency said. It chose the companies out of more than 100 companies by corporate size, demonstrated the record of quality and organizational excellence, clinical focus area and product risk profile.
The companies will provide access to measures they currently use to develop, test and maintain their software products and allow FDA site visits, among others.
Once a company passes the FDA test, it will become “pre-certified” which would enable it to potentially “submit less information to the FDA than is currently required before marketing a new digital health tool,” it said.
The FDA also said it is also considering letting pre-certified companies not submit a product for premarket review.
The program's developments will be available via its pilot program website.
<© Korea Biomedical Review, All rights reserved.>