The Institute of Medicine (IOM) has released a report highly critical of the FDA's 510(k) medical device clearance process and called on the FDA to develop "a new framework that used both premarket ...

(click to enlarge)A history of medical device regulatory benchmarks. The 510(k) process has been used to clear about 90% of medical devices for U.S. marketing since its inception in 1976. Yet to many ...

As part of its fact-finding process, the Institute of Medicine (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process provided an opportunity for public comments on ...

Due to increasing complexity of modern technology, FDA should consider updating its 510(k) process. Devices are not drugs. That is to say, the requirements for safe and effective drugs and devices ...

Prior to the Medical Device Amendments (MDA) of 1976, medical devices generally had not undergone premarket review by the US Food and Drug Administration (FDA). The MDA created three classes of device ...