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.
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An update by the US agency to its MedWatch 3500A adverse event reporting form targets summarized events and patient gender. The FDA is also updating its electronic Medical Device Reporting (eMDR) system to accommodate the changes made to the 3500A, among other revisions.
FDA Ends Summary Reporting Program, Releases 20 Years Of Adverse Events, Vows To Make MAUDE 'User-Friendly'
The US FDA today formally shuttered its Alternative Summary Reporting (ASR) Program and released to the public millions of adverse event reports received by the agency between 1999 and 2019. The FDA also wants to make its Manufacturer and User Device Experience (MAUDE) database – where all adverse events are stored – easier to use.
FDA Quietly Sunsetting Summary Reporting Program For Adverse Events, Readies Public Release Of Millions Of Pre-2017 Summarized MDR Reports
The US FDA expects to turn the lights out on its 22-year-old Alternative Summary Reporting Program for adverse events at the end of May, the agency tells Medtech Insight. But it's the FDA's upcoming online release of millions of summarized Medical Device Reports sent to the agency between 1998 and 2017 that could have the tongues of industry – and the public – wagging.