The US Food and Drug Administration is updating for the first time in nearly seven years its guidance on how medical device manufacturers can use national and international voluntary consensus standards in their applications for market approval1,2.
The US Food and Drug Administration is updating for the first time in nearly seven years its guidance on how medical device manufacturers can use national and international voluntary consensus standards in their applications for market approval1,2.
The FDA has issued a draft guidance document to help device manufacturers and agency reviewers understand how they can use...
A surgeon at Ochsner Health in New Orleans was able to successfully remove a rare and dangerous tumor from a patient’s spine using cutting-edge technology that would have otherwise made the procedure too risky.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
