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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
The FDA announced the nine participants selected for its first digital health software pre-certification pilot program, ranging from startups to giants in the space. Read More
3D printing is poised to transform the medical device industry, according to several players in the space who participated in a recent FDAnews webinar. Read More