FDA Requiring Companies to File Electronic Reports on Adverse Events

The U.S. Food and Drug Administration (FDA) is requiring medical device manufacturers submit electronic reports of injuries or deaths associated with their products, according to a final rule recently issued by the agency.

Electronic submissions will make it easier for the FDA to review adverse events and rapidly communicate information about suspected problems to the medical device industry, healthcare providers, consumers and other government agencies, the agency said in its rule.

For decades, the FDA has received these reports in a paper format through the mail. In 2009, the agency released a proposed rule that called for electronic reports on a voluntary basis. The final rule makes it mandatory to do so starting Aug. 14, 2015.

The FDA on average receives roughly 200,000 adverse events annually and can take anywhere from three days to six to properly analyze a report received by mail, according to the FDA. Others argue it could be even longer in some instances.

“It is no secret that, for years, paper medical device reports were mostly warehoused,” said Jeffrey Shapiro, an attorney at Hyman, Phelps & McNamara.

The FDA estimates it 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, the FDA estimated. However, devicemakers will save about $9.2 million annually because electronic submission should reduce the time needed to submit documents and reduce delivery costs.

A major change between the proposed and final rule: user facilities such as hospitals will not be required 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 are not exempt from the new requirement, however.

“There are many very small device manufacturers and I believe that this is going to be a burden for them,” said Wally Pellerite, an industry consultant and former FDA compliance official, adding that it makes the agency appear inconsistent to exempt hospitals but not small devicemakers. “Small device firms with few medical-device reports should be allowed to submit paper reports.”