Firms With Rocky MDR Compliance Histories Shut Out Of FDA Adverse Event Program
The US agency has updated its Medical Device Reporting website with information on which products qualify for its Voluntary Malfunction Summary Reporting program for adverse events, and which don’t.
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Makers Of An Array Of Devices Can Now Report Malfunctions In Summaries To FDA. Did Your Product Make The Cut?
US FDA rolled out its Voluntary Malfunction Summary Reporting Program on Aug. 17, allowing device-makers and manufacturers of device-led combination products to send quarterly rollup adverse event reports to the agency. The program's overarching goal is for FDA to receive fewer individual Medical Device Reports and to lessen the time firms spend preparing them, while maintaining sufficient detail for the agency to effectively monitor devices.
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.
Digital Health Roundup: Exec Chats With Illumina, Bloom, AngelMed; M&A, Funding; FDA Down-Classifies Apps
In this roundup feature focusing on new developments in digital health, Medtech Insight spotlights IBM Watson Health’s divestiture and other financing news, Exec Chats with Illumina, AngelMed and Bloom, Philips’ new hand-held ultrasound device and autonomous robotic surgery, as well as the latest FDA news on digital health.