For a medical device to be marketed in the United States, it must go through a regulatory process outlined by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and enforced by FDA. 1 For most ...

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 ...

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 ...

AUSTIN, Texas — On the way to adopting low-k dielectrics, the world's largest foundry has run smack into a problem that is proving difficult to solve. Although Taiwan Semiconductor Manufacturing Co.

Axcelis Technologies Inc. of Beverly Mass., and Dow Corning Corp. of Midland, Mich., today said they are collaborating on the development of a process that will allow the use of porous ultra-low-k ...