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printed December 15, 2017
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Apple, Samsung, Fitbit Join FDA Trial for Faster Health Device Approval

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Sep 27, 2017, 9:29 AM   by Rich Brome   @rbrome

The U.S. Food and Drug Administration (FDA) this week announced the companies participating in a trial program designed to streamline government approval of health devices and software. Apple, Samsung, Fitbit, and Verily (an Alphabet company) are among the nine companies selected, out of over 100 that applied. The pilot program is called Pre-cert and will determine quality standards for a company's software design, validation, and maintenance. Companies that meet the new standards will become pre-certified, allowing them to submit less information to the FDA when submitting a health or medical device or app for approval. The pilot program includes site visits by FDA staff, and gathering feedback from the industry, stakeholders, and the public. The first public update on the pilot program will be shared in January 2018.

more info at FDA »
more info at Engadget »

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