FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...

Researchers at the Yale School of Medicine have found that the Food and Drug Administration’s De Novo pathway — a process of making risk-based evaluations of certain medical devices — has cleared ...

ARLINGTON, Va.--(BUSINESS WIRE)--The National Evaluation System for health Technology Coordinating Center (NESTcc), an initiative of the Medical Device Innovation Consortium (MDIC), today announced ...

As important as innovations in medical device technology are to improving patient outcomes, the effectiveness of these new tools is difficult to gauge. A new report recommends the formation of a ...