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Companies that develop laboratory-developed tests should begin to incorporate design controls and establish a quality system ahead of the expected finalization of FDA guidance this year, experts advise. Read More
Newly released government data shows the FDA has been conducting more quality systems inspections at foreign devicemakers to keep up with rapidly growing inventory at those manufacturers. 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