FDA publishes draft guidance on wellness devices, medical device accessories regulation

January 16, 2015 | Reply More

The FDA’s draft guidance documents recently published, in compliance with actions outlined in its FDASIA Health IT Report, propose to regulate medical device accessories based on risks they present when used as intended with their parent devices and not regulate products intended only for general wellness. WLSA member company Epstein Becker Green’s health attorney Brad Thompson, gave comments to FierceHealthIT, saying “this guidance doesn’t go far enough and instead of solving current problems, suggests that the industry solve them itself.”

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