FDA seeks to modify regulation of medical devicesBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c4415 (Published 12 August 2010) Cite this as: BMJ 2010;341:c4415
- Bob Roehr
- 1Washington, DC
Regulation of medical devices in the United States could change if a series of recommendations by two internal working groups at the Food and Drug Administration (FDA) are fully implemented. The reports, released earlier this month, begin a process of public comment and possible modification before being implemented.
The focus is on so called 510(k) devices, known by the regulatory subsection under which they are evaluated. The section has three broad categories: high risk such as heart valves; …