FDA fast-tracks Apple health products | Cult of Mac

FDA fast-tracks Apple health products


Apple Watch Series 2 will still make you stare at their wrists waiting for it to wake, when you should be watching where you are running
The FDA is easing up on digital health tools like Apple Watch.
Photo: Graham Bower / Cult of Mac

The Food and Drug Administration is making it easier for Apple and other tech companies to get health-related products out to the public faster.

Apple will be part of a new pilot program aimed at rapidly advancing the development of digital health applications. If the program works as intended, it could mean we’ll see new Apple Watch applications and other Apple-made health accessories a lot sooner.

One of the biggest hurdles preventing Apple from turning its watch into a tool for diagnosis, treatment and prevention has been the FDA’s bureaucratic approval process. Now the company will be able to get a precertification that will allow it to submit products to the FDA for approval before shipping to consumers.

FDA’s new Pre-Cert pilot program

The FDA announced the participants in the Pre-cert pilot program this morning. Eight other companies will join Apple as the first wave of companies to test the new process.

“Our method for regulating digital health products must recognize the unique and iterative characteristics of these products,” said FDA Commissioner Scott Gottlieb. “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.”

Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily are also included in the pilot program.

Under the program, the FDA will evaluate a company’s systems for software design, validation and maintenance to determine whether the company meets quality standards. The information gleaned during the process will also be used to set the standards for the launch of a potentially bigger program involving more companies in the future.

Over 100 companies expressed interest in joining the pilot program when it was first announced this summer. The FDA says it will hold public workshops in January to discuss initial findings with the original nine companies, and to help other developers understand the process.


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