The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed list. Read More
FDA Commissioner Scott Gottlieb said the agency wants to encourage the development of medical devices designed specifically for pediatric patients and noted “there are still far too few devices on the market designed specifically to trea... Read More
Australia’s Therapeutic Goods Administration issued new guidelines on electronic instructions for use for medical devices. Read More
A litany of major GMP deficiencies — ranging from inadequate document control procedures, CAPA, device acceptance procedures and procedures to control product — plagued GEM City Engineering and Manufacturing during a Feb. 21 to March 1 F... Read More
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