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The FDA unveiled the new Combination Products Policy Council, which will have decision-making authority on issues relating to combination products, cross-labeled products and medical product classification. Read More
A Groveland, Fla.-based company has been taken to task by the FDA for a number of problems at its facility, including failure to identify actions to prevent recurrence of nonconforming products. Read More
CDRH soon will have three medical device divisions that are responsible for monitoring and managing the entire establishment inventory both domestically and globally, under its new program alignment. Read More
A new report from the Duke-Margolis Center for Health Policy is offering an initial peek into a planned coordinating center intended to guide the development and implementation of a postmarket device evaluation system. Read More
With an eye toward making the conduct of clinical studies more efficient, the FDA and NIH have unveiled a template intended for investigators writing Phase 2 or 3 trial protocols that require IDE applications. Read More