We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Evidence introduced by Cook to challenge the BSI patent had initially convinced the board of reasonable likelihood for the first 19 claims to be unpatentable. Read More
MDR reports often “describe the same problem, creating a process where the FDA conducts duplicate reviews of common malfunctions,” said CDRH Director Jeff Shuren. Read More
Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate device history records. Read More
The FDA said a “least burdensome” approach should be applied throughout the medical device product lifecycle, rather than just in premarket regulatory decisions. Read More
FDA medical device adverse event codes will soon be harmonized with IMDRF terminology — a move that is expected to benefit not just regulatory bodies, but devicemakers and consumers. Read More
The firm’s device history records for its recalled lots did not include the final quantity of products reviewed, approved and released for distribution. Read More