Move to Modernize

The proposed device rule, published in the Federal Register on Aug. 21, would not change the types of incidents that the agency requires be reported, but rather would mandate that the incidents be reported in an electronic format that the FDA can process, review and archive.

For years, FDA officials have complained about drowning in paperwork and a lack of up-to-date technology. They seem to be catching up on the technology side, and now they want the industry to follow suit. The new rules would “improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health. According to the Federal Register notice, approximately 57,000 manufacturers, importers and user facilities would be impacted. The agency typically receives about 100,000 reports each year, covering events such as deaths, serious injuries and malfunctions, with reports filed in five, 10 or 30 days, respectively, after each type of adverse event. Setting up the new electronic systems could cost the industry $58 million to $80 million in initial implementation costs, and would have an estimated annual $8.5 million price tag to maintain. However, the rule would save the industry $3.2 million a year and would save the FDA $1.25 million in operating costs yearly, according to the agency.

FDA officials said the move would eliminate its transcription errors, as well as the time and costs associated with receiving paper reports and transcribing data to an electronic format. The conversion also would expedite access to safety information in a format that supports data analysis and reviews, in addition to enhancing FDA’s ability to rapidly communicate information about suspected problems to the industry, healthcare providers, consumers and government agencies. Manufacturers, importers and user facilities would load eMDRs into the FDA’s Manufacturer and User Facility Device Experience (or MAUDE) database. The system provides a choice of two electronic options for reporting post-market safety information. Small manufacturers with a limited number of reports may prefer an application known as eSub, which runs on free software available from the FDA. Large firms, which often submit hundreds of reports per year, may be better off using a batch submission protocol based on a widely recognized informatics standard, according to the FDA. The proposal does not apply to reports submitted on a voluntary basis. The FDA will accept comments for 90 days before the final rule is published, and the new rule will become effective one year after the final version is released in the Federal Register.

“Though the FDA has been equipped to accept reports electronically for several years, few companies have made the switch to electronic systems for submission as the process is materially different in both technology and process, which has resulted in apprehension,” Mike Jovanis, vice president of product management for Sparta Systems—a provider of enterprise quality management software based in Holmdel, N.J.—told Orthopedic Design & Technology. He said the proposal gives companies a firm deadline to upgrade their systems and noted that the industry has been expecting eMDR regulation for some time, but the “lack of a clear mandate” placed the switch to electronic submission low on companies’ priority lists. “Forward-thinking organizations have been preparing for the switch by proactively investing in enterprise-wide quality systems to streamline collection and submission processes,” he said. “Organizations that are proactive in embracing technology have been the lead users in the adoption of the new electronic standard. Those that are more apprehensive about technology have taken a more conservative wait-and-see approach.”

Ultimately, this new mandate should be considered an opportunity for efficiency gains, Jovanis said.

Christopher Delporte
Group Editor