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The voluntary Medical Device Development Tools program is intended to facilitate finding measuring tools to help streamline regulatory reviews. Read More
Devicemaker Kelyniam Global drew a warning letter from the FDA after failing to adequately address numerous GMP issues observed in a May inspection of its Canton, Connecticut facility, including the manufacturing of unapproved implants. Read More
The FDA cited a German medical device manufacturer for noncompliance issues related to MDR reports, complaint handling, as well as device master records and history records. Read More
The firm promoted several intended uses for the devices, such as for endometriosis and Crohn’s diseases, that have not been evaluated by the FDA. Read More