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 will host an advisory committee webcast to discuss approval of the company’s new heart transplant device a year after it was originally planned.
The Q-Collar is meant to work by improving blood flow to the brain, and has been shown to reduce signs of trauma from head impacts when playing sports.