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Consumer-'Empowering' Devices Called Out In Gottlieb's First FDA Speech

 
• By David Filmore

New US FDA Commissioner Scott Gottlieb made only one direct mention of medical devices in his first speech to the agency, highlighting the promise of devices that empower consumers to be "better stewards of their own care." Gottlieb has been a strong proponent of FDA largely staying out of the oversight of many products in this category, in particular, DTC gene tests and digital-health tools.

FDA Commissioner, Scott Gottlieb, holds FDA All-Hands
US FDA Commissioner Scott Gottlieb delivers his May 15 "All Hands" address to agency staff. • Source: Courtesy of FDA

Scott Gottlieb's first speech as commissioner to US FDA staff included only one direct mention of medical devices, referencing realms of technology that Gottlieb has previously urged the agency to stay out of as much as possible: direct-to-consumer genetic testing and digital health.

Gottlieb, who was sworn in as FDA commissioner May 11, delivered his first address to the agency during an "All Hands" meeting on May 15; the

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