The Food and Drug Administration has announced that Apple, Samsung, Fitbit and a handful of other companies are participating in a new pilot program that will accelerate the digital health regulations in the U.S. During the AdvaMed MedTech Conference in San Jose, California, the FDA revealed the digital health software precertification pilot program
Major nine companies including Samsung, Apple, Fitbit, Pear Therapeutics, Roche, Johnson & Johnson, Pear Therapeutics, Tidepool, and Verily are participating in the scheme.
The program had attracted over 100 interested companies, and the FDA selected the above nine companies considering some aspects such as company size and risk profile of the products.
FDA commissioner Scott Gottlieb said that the program called Pre-cert was initially launched on July 27th. The companies those are participating will provide access to the methods they use to test, maintain, and develop their different products as well as provide the information about data collection methods and quality maintenance to the FDA.
Scott said, “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 organization shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product,” he added.
FDA is trying to regulate uncertain territories as direct-to-consumer health products have faced many barriers in the past. Hopefully, the Pre-cert program could lead to generating new tech health products in the market faster.