FDA Releases Final Guidance On Postmarket Surveillance Of Medical Devices

The US Food and Drug Administration (FDA) has issued final guidance for manufacturers subject to postmarket surveillance requirements of certain Class II and Class III medical devices under Section 522 of the US Federal Food, Drug and Cosmetic Act (the Act), as amended by Section 212 of the Food and Drug Modernization Act (FDAMA) of 1997, and Section 212 of the Food and Drug Modernization Act (FDAMA) of 1997.
Source: Medical Design Online News - Category: Medical Equipment Source Type: news