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.
Sponsors of medical devices should submit a declaration of conformity, certifying compliance with the standards on a list maintained by CDRH. 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 number of investigational device exemptions submitted under CDRH’s Early Feasibility Study Program has more than doubled, with 57 submitted in FY 2017 up from 26 when the agency issued EFS guidance in 2013. Read More
The percentage of FDA-approved clinical trials that include patient-reported health outcomes has reached 80 percent, CDRH Director Jeff Shuren said at the FDA/CMS Summit. Read More
China FDA will soon begin accepting foreign clinical data for medical devices as part of a national effort to promote industry innovation and to… Read More
The guidance covers the use of recognized standards, drug-device combination products, investigator-sponsored investigational testing, and stages of product development. Read More
The new guidance provides details on the clinical trial data needed to assess safety and efficacy of medical devices and in vitro diagnostics intended for registration in China. Read More
The FDA is finalizing guidance that urges sponsors to minimize device design changes in generic drug delivery products, and outlines how differences could threaten substitutability. Read More