eMDR 101: Experts Show Companies The e-Submissions Ropes

Full article reprinted from "The Gray Sheet" - December 7, 2009

Though the date to comply with FDA's new electronic adverse event reporting requirements is still some time away, groups are already gearing up to guide firms through the complex new process. Read more...

eMDR 101: Experts Show Companies The e-Submissions Ropes

Full article reprinted from "The Gray Sheet" - December 7, 2009 

Though the date to comply with FDA's new electronic adverse event reporting requirements is still some time away, groups are already gearing up to guide firms through the complex new process.

AdvaMed's Medical Technology Learning Institute (MTLI), for one, is launching a series of webinars to help member companies comply with the regulations. And companies such as compliance and adverse event reporting software maker Sparta Systems are offering seminars and other resources to help firms transition to the new system.

The regulation that will mandate electronic Medical Device Reporting (eMDR) and eliminate paper reports was just proposed in August and a final rule could be months away, but device companies should familiarize themselves with the available e-reporting options, says AdvaMed's Jeffrey Secunda, VP-technology and regulatory affairs.

"It's not because we anticipate problems with the rule," he said of the educational sessions, but companies "have a decision to make, and we're going to assist them."

Sparta System's Joby George said the firm has noticed "a significant up-tick" in questions about eMDR: "what it is, when it will be mandatory, how companies can ensure a smooth transition, how to change internal processes, etc."

"There's still a lack of understanding from med device manufacturers on where to begin," George said. But the process is not as convoluted as some companies think, he explained. "The challenge is to ensure internal buy-in."

Device companies should assemble a team with IT, regulatory affairs and quality assurance staff to help plan, design, build, test and implement the new electronic system, he suggested.

According to Deborah Kacera of compliance solutions firm Pilgrim Software, who led the Dec. 1 MTLI webinar, the eMDR process boils down to two essential steps: building the eMDR data file and transmitting it to FDA.

Companies are already collecting and reporting the necessary information, she said; they just need to invest the time to adopt the "very lean and efficient" eMDR process - the sooner, the better.

The proposed rule would give firms one year after publication of the final rule to comply with eMDR requirements, and some firms are lobbying for a longer window (The Gray Sheet' Nov. 30, 2009).

But Kacera urges companies to gain access to FDA's e-submissions experts now, before there are "ten thousand other medical device manufacturers knocking on the FDA's door."

"If you postpone it, you will probably have less and less availability of FDA resources for any guidance," she said.

Same Info, New Format

Manufacturers, importers and user facilities are required by law to submit certain mandatory adverse events to FDA using the Medwatch Form 3500A. Currently, FDA manually inputs data from the paper submissions into the agency's MAUDE adverse event database, a process that can take anywhere from three days to more than six months.

"All of the same data elements that are in the Medwatch report are still part of this eMDR electronic data file," Kacera explained. "We're taking that Medwatch form and we're mapping it into an XML file."

Before companies begin weighing different eMDR options, Kacera recommends they read through FDA online materials, particularly its Electronic Submissions Gateway site.

For example, the ESG  user guide, updated Oct. 23, gives detailed implementation steps.

There are different options available to companies that submit few, or many, MDRs.

Low-volume submitters can build eMDR files one at a time using free "eSubmitter" software available for download on FDA's Web site. They can then transmit the files to FDA using the agency's online "Web Trader" tool.

High-volume submitters will likely prefer to use custom-made software to build and transmit the files. Many companies already use these so-called "b2b" (business-to-business) tools to generate MDRs for FDA.

If firms have multiple divisions, "especially if you've got any kind of pharma sister division, check to see if they're already using a b2b," Kacera recommends. "Chances are: they are. Leverage what you already have as far as your cash investment."

Transitioning to an electronic process will not be without costs, but FDA estimates that the expenses, particularly for small companies, will be "small."

Because most device companies are small, FDA anticipates most firms will take advantage of the free eSubmitter and Web Trader tools. Those options are "very, very cost-effective," Kacera said.

FDA estimates the eMDR system will ultimately save FDA and industry $1.25 million and $3.2 million a year, respectively.

- Jessica Bylander

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