By MacRumors Staff

FDA Articles


Apple Joins FDA Pilot Program for Faster Approval of Digital Health Tools

Tuesday September 26, 2017 11:03 am PDT by
The Food and Drug Administration today announced that it has selected nine companies to join its voluntary Pre-Cert pilot program, which is designed to foster innovation through the creation of a less restrictive regulatory framework that will lead to faster acceptance of health-related software and, in some cases, products. Companies accepted to the program include Apple, Fitbit, Johnson &...
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FDA Taking 'Almost Hands-Off Approach' to Regulating Apple Watch and Similar Wearables

Monday March 30, 2015 6:21 am PDT by
As Apple and other companies create products capable of providing more and more detailed health-related information, the U.S. Food and Drug Administration has decided to give the companies creating these devices breathing room to manufacture the devices free, for the most part, from the scrutiny of the agency (via Bloomberg Business). The FDA's associate director for digital health, Bakul...