DrBicuspid

FDA targets improvements to 510(k) process

With an eye toward encouraging innovation, providing regulatory predictability, and ensuring patient safety, the FDA's Center for Devices and Radiological Health (CDRH) has issued two preliminary ...
EDN

Sematech accelerates low-k process to development fab

SAN FRANCISCO — During the Semicon West trade show here today, International Sematech announced it has transferred a low-k baseline process to its 200-mm pilot fab one month ahead of schedule. The ...
EDN

Amkor preps packages for TSMC’s low-k process

Chandler, Ariz. – Amkor Technology Inc. is developing chip-packaging products based on Taiwan Semiconductor Manufacturing Co. Ltd.'s low-k dielectric process, claiming the companies are addressing ...
National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

To gain a foundation on which to build its discussions, the committee commissioned two former Center for Devices and Radiological Health (CDRH) staff to draft a background paper on the 510(k) or ...