Medical Device Cos. May See Rule to Report Malfunctions Relaxed

Medical device makers big and small may soon be required to report device malfunctions just four times a year instead of within 30 days of an incident.

Medical Device Cos. May See Rule to Report Malfunctions Relaxed
Devices such as insulin pumps would be subject to the potential rule change. (Photo by Medtronic)
UPDATE: On Wednesday afternoon, the U.S. House of Representatives approved the proposed agreement between the Food and Drug Administration and the medical device industry to lengthen the time to report malfunctions. The Senate will be the next to vote on the bill.
The hundreds of medical device companies that call Minnesota home, as well as others around the nation, may soon be allowed to report malfunctions of their products quarterly instead of within 30 days of an incident.
The U.S. House of Representatives will vote on the relaxation of the rule on Wednesday.
Every five years, medtech industry executives and representatives from the Food and Drug Administration renegotiate the pact. The agreement, as reported by the New York Times, also decides what fees a company would need to pay for their product to be reviewed and ultimately approved for sale in the U.S.
If passed by the House (and later the Senate), the new rule could triple the time medical device makers have to report on malfunctions or cases where a product is not working as intended and has the potential to cause injury. However, instances where a device seriously injured a patient or led to their death would still need to be reported within 30 days.
About 430,000 people work within health care and related sectors in Minnesota, state data indicates. Minnesota boasts the largest per-capita cluster of health tech inventors in the world, according to Golden Valley-based Medical Alley Association.
The New York Times reports on both the criticism and advocacy for the new agreement, which could subsequently force the FDA to make its approval process “faster than ever.”
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