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Congress’s failure to pass a government funding bill last weekend means much — but not all — of FDA’s work will stop until an appropriations bill is passed. Read More
“We aim to have more than 50 percent of manufacturers of novel technologies…intend to bring their devices to the U.S. first or in parallel with other major markets by December 31, 2020,” said CDRH Director Jeff Shuren. Read More
DoD’s Office of Health Affairs and the FDA will collaborate in reviewing products meant to treat, prevent or diagnose serious or life-threatening conditions for troops. Read More
The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant CGMP violations. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
The Apex system “offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care,” the company said. Read More
The FDA said in a new draft guidance a “least burdensome” approach should be applied throughout the medical device total product lifecycle, rather than just in premarket activities. Read More