Last week, the U.S. Food and Drug Administration (FDA) announced the names of companies that will participate in its digital health software precertification pilot program (FDA Pre-cert). Some of the world’s biggest tech players are joining the FDA to help devise a top-down approach to adhere to standards the agency sets.
Instead of reviewing thousands of apps individually, the FDA will look at the companies making software and determine if they meet the agency’s criteria.
In a statement, U.S. FDA Commissioner Scott Gottlieb, M.D. said:
“We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate, and helps foster beneficial technology while ensuring that consumers have access to high-quality, safe and effective digital health devices.”
After the FDA announced its Pre-cert pilot in July, in conjunction with its Digital Health Innovation Action Plan, they received interest from over 100 companies. They whittled down this group based on size, record of quality, and clinical focus. Apple, Fitbit, Johnson & Johnson, Verily, and Samsung are among the final 9.
Pre-cert pilot participants will share metrics for developing, testing, and maintenance of their products. FDA staff will be allowed to visit the companies. The public will be able to give feedback and can expect updates of this program via a web page and workshops.
