Benefits Of FDA's New Premarket Device Exemptions Not Clear, Attorneys Say

Benefits Of FDA's New Premarket Device Exemptions Not Clear, Attorneys Say-insidehealthpolicy: Industry attorneys said recent guidance announcing FDA's intention to exempt certain low-risk devices from premarket notification requirements could have limited benefits. One attorney said he initially saw the guidance as a "huge boost" to industry, especially mobile health manufacturers, but now believes the ambiguous guidance might not actually exempt as many products as expected.