Electronic Adverse Event Reporting Would Be Mandatory Under FDA Proposal

Article perview reprinted from "The Gray Sheet" - August 24, 2009

Device manufacturers would have to submit adverse event reports to FDA electronically under a draft rule issued Aug. 20. Read more...

Electronic Adverse Event Reporting Would Be Mandatory Under FDA Proposal

Article perview reprinted from "The Gray Sheet" - August 24, 2009

Device manufacturers would have to submit adverse event reports to FDA electronically under a draft rule issued Aug. 20.

The proposed 1 regulation, published in the Federal Register Aug. 21 with draft 2 guidance, could help FDA move from relying on paper-based processes to oversee product safety. Similar proposals were introduced for drug and biologics makers.

For the device industry, the proposed reg would require manufacturers, importers and user facilities to submit medical device reports (MDRs) to FDA using one of two electronic submission systems. Once processed, the reports - which concern deaths, serious injuries and malfunctions associated with medical devices - would be loaded automatically into FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

FDA says the new system will save time and money for government and industry. FDA will save about $1.25 million annually in data entry costs, and the device industry will save around $3.2 million.

Above all, FDA touts the public health benefits of an all-electronic safety reporting system. "The agency would have quicker access to the medical device adverse event reports information and thus could more quickly identify and act on any medical device problems," the proposed rule states.

The electronic MDR system would eliminate transcription errors, give FDA faster access to safety information, and allow it to more quickly communicate that information to the device industry, health care providers, consumers and other government agencies, the agency says.

- Jessica Bylander

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