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

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. FDA released guidance Aug. 1 announcing its intent to exempt certain class II and class I medical devices from premarket notifications. The list includes anesthesiology, cardiovascular,...