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.
Listing the device would improve the quality of healthcare by enhancing tracking information on implants like cardiac stents and artificial joints, the lawmakers said. Read More
Sens. Chuck Grassley (R-Iowa), Elizabeth Warren (D-Okla.) and three representatives urged the Centers for Medicare & Medicaid Service to begin including information from unique device identifiers (UDIs) for high-risk implants on electronic insurance claims. Read More
The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to sponsors who wish to submit a 510(k) application using the agency’s Safety and Performance Based Pathway. Read More
GSK demanded that BI stop using a brochure which claimed that a majority of COPD patients would be unable to fully benefit from Ellipta and Diskus. Read More
Most comments supported aligning the classification levels with either the EU Medical Device Regulation or the classification principles of the International Medical Device Regulators Forum. Read More
“BioCorRX and the [Louisiana Department of Public Safety and Corrections] conducted what clearly amounts to a clinical investigation testing a sustained-release naltrexone implant in prison inmates,” according to the Public Citizen petition. Read More