Devicemakers Likely ‘in Crosshairs’ for Tough Off-Label Enforcement

Devicemakers should pay more attention to prior FDA feedback on product promotions if they want to avoid the agency’s growing attention to promotional violations, legal experts suggest. A recent analysis by attorneys at Hyman, Phelps & McNamara found that between May 1, 2012, and April 30 of this year, CDRH issued 24 letters for promotional claims.
Devices & Diagnostics Letter