The program, called Pre-cert, will include Apple, Fitbit, Samsung, Alphabet-owned Verily, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, and Tidepool.
The program had attracted over 100 interested companies, and the FDA made its selections based on factors like company size and risk profile of the product(s).
The FDA’s usual timeline for approving new products can often take months, which can delay developers as tech advances faster than the agency can approve it.
The companies that participate must provide access to the methods they use to develop, test, and maintain their products as well as give information to the FDA about how they collect data and maintain quality.
Direct-to-consumer health products have faced multiple roadblocks in the past as the FDA tries to keep up with how to regulate unknown territories.