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.
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
“If we can’t work everything out, that’s fine. Let’s just put pen to paper on what we have worked out and maybe enter part of the puzzle,” said Shuren. Read More
The FDA’s regulatory process for manufacturers of new moderate-risk devices has “remained largely unchanged since it was first implemented 40 years ago,” Commissioner Scott Gottlieb said. Read More