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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
Government Accountability Office researchers visited eight devicemakers in connection with a new report on diagnostic medical devices and found that the regulatory review process poses an obstacle to applying the technology in the marketplace. Read More
Early human-factor studies can address many questions on usability before combination products enter clinical testing, according to John Towns, a senior research fellow at Eli Lilly & Co. Read More