Apple joins FDA program to speed up health software approval process

Since the Apple Watch’s creation, the FDA has mostly maintained a hands-off approach to regulations, and as Apple pushes into new areas of health monitoring the agency is looking to help the company avoid regulations that have slowed development on health software, Bloomberg reports. The program will allow companies to pre-clear their products instead of going going through the usual months-long application and approval process. The program is aimed at helping companies develop new products more rapidly while still keeping some government oversight of the process. “We need to modernize our regulatory framework so that it matches the kind of innovation we’re being asked to evaluate,” FDA Commissioner Scott Gottlieb said.
Under the Pre-Cert for Software Pilot, the FDA will go over a health company’s software and inspect their facilities before granting pre-certified status. After that status is granted, the company will face a less stringent approval process or in some cases be able to skip FDA approval all together. “Historically, health care has been slow to implement disruptive technology tools that have transformed other areas of commerce and daily life,” Gottlieb said, calling the new process “a new and pragmatic approach to digital health technology.”

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