Electronic Adverse Event Reporting Will Soon Be Mandatory, FDA Says

From the October 1, 2007, issue of "The Gray Sheet"

FDA is urging device manufacturers to voluntarily adopt the agency's electronic Medical Device Reporting (eMDR) process in anticipation of being required to do so as early as next spring.

The eMDR program is intended to help CDRH more easily identify patterns in adverse events.

The program is currently optional, but a draft rule mandating electronic reporting is being completed within CDRH and will likely be released for public comment by February, Don St. Pierre, head of FDA's Postmarket Transformation Management Group, said Sept. 25 at the Regulatory Affairs Professionals Society annual meeting in Boston.

"I can guarantee you the center will be done with those comments very quickly to move that final rule forward," St. Pierre said. "So you can do [electronic reporting] now or you can wait for it to be done to you."

So far, only 15 eMDRs have been filed with FDA, all by one company, he said. St. Pierre noted that the agency needs more submissions to determine how well the program is working.

"It would really help us to figure out how to make this better if all of you would start using it. So tell your management to seriously consider doing this," he told RAPS participants.

Another goal of electronic reporting is to reduce the overwhelming number of paper adverse event reports submitted by manufacturers. Paper reports must be entered into FDA's database manually at great expense, St. Pierre noted.

"We spend tons of money on our contract for entering MDRs into our system," he said. "We could ... use that money elsewhere. Whether that's in the premarket area, whether that's in the communications area, wherever - it could be better spent than where it's being spent now."

- Shawn M. Schmitt

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