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.
Device Week, 30 October 2020 – Medtech Money Influences US Elections; User-Fee Negotiations Kick Off
In this week’s podcast we discuss which political candidates are getting campaign donations from the medtech industry in the 2020 US Senate and House elections, and where the FDA and other stakeholders – including the medtech industry – stand as device user-fee negotiations get underway.
The US agency has added gaseous-phase carbon-dioxide gas analyzers to its list of products that – during the coronavirus pandemic – will not require a new premarket notification to be marketed for remote monitoring.