Search Results for: Medical Device Regulatory Modernization Act Of 1997

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its asse

To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent r

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions i