FDA

FitBit, Apple Join FDA’s Program to Pre-Certify Select Health Tech Companies

In an effort to allow a select group of health technology companies to avoid some regulations that have tied up developers working on health software and products, the U.S. Food and Drug Administration (FDA) has selected nine major tech companies for a pre-certification pilot program, Bloomberg is reporting. Apple and FitBit, the two leading health tech companies, are both...

Apple Holding Secret Meetings with Food and Drug Administration

According to a report by Business Insider, Apple has been holding secret meetings with the Food and Drug Administration (FDA) over the past few years, discussing "diagnostic apps and other unreleased health products”. Meetings with Apple officials were not listed on FDA public calendars, and were discovered by Mobi Health News, which obtained emails between Apple and FDA through...

FDA Relaxes Regulation of Fitness Wearables Like Apple Watch

As Apple, Samsung, and other companies are stepping into the new market of wearable computers packed with sensors, the Food and Drug Administration has decided to take a soft approach to regulating the players of the new market. The move was suggested by earlier reports, but now Bloomberg cites FDA officials giving the green light...