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China has witnessed a bevy of changes to device regulations over the past couple of years. So what should devicemakers keep in mind to avoid running afoul of regulations? Read More
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