Pat Shrader, Medtronic’s vice president for global regulatory affairs, testified (PDF) at a House subcommittee hearing this week, urging Congress to “improve” the inspection of medical device manufacturing facilities.
The FDA inspects device manufacturers to ensure they are complying with regulatory requirements. And when devicemakers fail to meet standards, the agency responds with warning letters, recalls and the like.
But Shrader pointed to “vast discrepancies” in inspections, which result in different facilities—across the same company or for different companies—being held to different standards based on their location.
Speaking before the House Energy & Commerce Health Subcommittee, she said the agency doesn’t usually give devicemakers enough of a heads up.
“This short notice, plus the often erratic schedules of investigators, leads to challenges in assembling the appropriate team members to provide the required documents and materials requested by the FDA,” Shrader explained.
Speaking on behalf of the Advanced Medical Technology Association, Shrader spoke in favor of the bill H.R. 1736, sponsored by Rep. Larry Bucshon, R-Ind., The bill proposes to standardize inspection processes, increase transparency in export certification and encourage risk-based inspections, which would would involve scheduling routine inspections of device manufacturing plants around each company’s history of compliance.
Medtronic has a number of plants that make class III devices—the most serious kind—which have “positive compliance profiles,” but are still inspected several times a year, Shrader said. A risk-based schedule would allow the FDA to allocate its resources toward inspecting facilities that pose more “significant risks to public health," she said.
"Risk-based inspections makes sense to me," said Dr. Michael Carome, medical director of the consumer rights advocacy group Public Citizen, according to the StarTribune. "But I think it is more important that the FDA inspect facilities that make high-risk implantable devices."