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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
The voluntary Medical Device Development Tools program is intended to facilitate finding measuring tools to help streamline regulatory reviews. Read More
The potential benefits of MPOCTs include improved patient health care and management, more appropriate use of antibiotics, limiting the spread of disease and cost savings. Read More