The Food and Drug Administration announced the names of the companies selected to participate in a pilot program that it says "will help revolutionize digital health regulation in the U.S."

The FDA's Pre-cert pilot program is intended to "inform a tailored approach toward digital health technology by looking at the software developer or digital health technology developer, rather than primarily at the product." The goal is for the FDA to, "after reviewing systems for software design, validation and maintenance, determine whether the company meets quality standards and if so, to precertify the company." It added, "The agency hopes to determine the key metrics and performance indicators for precertification and identify ways that precertified companies could potentially submit less information to the FDA than is currently required before marketing a new digital health tool as part of a formal program.

The FDA is also considering, as part of the pilot program, whether and how, precertified companies may not have to submit a product for premarket review in some cases." Participants selected are Apple (AAPL), Fitbit (FIT), Johnson & Johnson (JNJ), Pear Therapeutics, Phosphorus, Roche (RHHBY), Samsung (SSNLF), Tidepool and Verily.