FDA plans electronic medical device reports

A conversion seen costing industry $58 million to $80 million

The Food and Drug Administration’s Medical Device Reporting system is being readied to convert to an electronic system.

Under a proposed rule, about 57,000 makers and users of medical devices would have to switch from paper reporting to electronic submissions of reports of adverse events related to medical devices. The postmarket reporting covers devices that are being sold and distributed to patients.

The FDA typically receives about 100,000 of those reports each year that cover events such as deaths, serious injuries and malfunctions. The reports are filed in five days, 10 days or 30 days after the adverse event.

Setting up the new electronic systems would cost the industry about $58 million to $80 million in initial implementation costs, and would cost $8.5 million a year to maintain, according to a notice published Aug 23 in the Federal Register.

However, the rule also would save industry $3.2 million a year and would save the FDA $1.25 million in operating costs yearly, the notice states. “The principal benefit of this proposed rule would be the public health benefits associated with more rapid processing and analysis of the 100,000 initial individual Medical Device Reports currently submitted to FDA on a paper FDA Form 3500A,” the notice states.

The FDA said the rule's benefits would include reducing industry time and costs, and eliminating the agency's transcription errors, time and costs associated with receiving paper reports and transcribing data to electronic format for review and analysis. The agency also said the conversion would expedite its access to safety information in a format that supports data analysis and reviews and enhance its ability to rapidly communicate information about suspected problems to the medical device industry, health care providers, consumers and other government agencies.

Comments are due by Sept. 21.

The FDA has several IT projects in the works; however, the Government Accountability Office recently reported that the agency does not have a strategic plan to guide its IT initiatives.

 

About the Author

Alice Lipowicz is a staff writer covering government 2.0, homeland security and other IT policies for Federal Computer Week.

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