FDA mandates e-reports on device adverse events

The Food and Drug Administration gave devicemakers another 18 months to comply with electronic filing of adverse event reports, a move long sought by safety advocates. Replacing the current paper system will make it easier for the FDA to track injuries and deaths associated with devices and rapidly communicate suspected problems to devicemakers, healthcare providers, consumers and other government agencies.

The final rule replaces a 2009 proposal that called for voluntary electronic reporting. The FDA receives roughly 200,000 adverse event reports annually, often by mail, and it can take three to six days to properly analyze a report, according to the FDA.

Others say it takes even longer—or doesn't take place at all. “It is no secret that, for years, paper medical-device reports were mostly warehoused,” said Jeffrey Shapiro, an attorney at Hyman, Phelps & McNamara. Electronic filing should enable more rapid and extensive analysis of data trends.

The FDA oversees more than 20,000 device manufacturers and importers. The industry will face one-time costs of $40 million in training and IT changes to make the switch, according to the final rule. However, devicemakers will save about $9.2 million annually because electronic submission will reduce the time needed to submit documents and lower delivery costs.

Hospitals got a major break under the final rule: They won't have to comply with the e-filing requirement. “This change from the proposed rule was obviously in response to comments concerning the increased costs for electronic submissions by entities that file a small number of reports each year,” said William Kitchens, a partner at the law firm Arnall Golden Gregory.

Small devicemakers lost their bid to be exempted from the new requirement, however. “This is going to be a burden for them,” said Wally Pellerite, an industry consultant and former FDA compliance official. He slammed the agency's willingness to bend for hospitals but not small devicemakers. “Small device firms with few medical-device reports should be allowed to submit paper reports,” he said.

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