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.
The company will pay $11.5 million to resolve allegations that it caused false claims to be submitted to government healthcare programs for procedures involving an unapproved drug-delivery device. Read More
The Association of Indian Medical Device Industry said Indian devicemakers were ready to comply with the new rules and they should be implemented as soon as possible. Read More
Medical product sponsors and researchers should work with electronic health record keepers to help improve clinical trial accuracy and efficiency, the FDA said in a new guidance. Read More
Stakeholders asked the FDA to clarify its proposal to expand the Abbreviated 510(k) program by allowing the use of performance criteria for demonstrating substantial equivalence. Read More
The agency said applicants should determine the biocompatibility of all parts in the biliary stent and the delivery system that touch the patient. Read More