U.S. senators Chuck Grassley (R-IA), Richard Blumenthal (D-CT) and Herb Kohl (D-WI) have introduced the Medical Device Patient Safety Act. The legislation would give FDA “important tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices.” In addition, the measure would allow the agency to order post-marketing clinical studies for 510(k) devices that pose potential safety risks. It would also implement Government Accountability Office recommendations for improving recalls and give FDA new authority to require conditional clearance pending safety studies for 510(k) devices.
“This reform legislation should be part of the reauthorization of the medical device user fee law next year,” Grassley said. “The reforms incorporate well-founded recommendations from the Government Accountability Office and reflect the value of having a robust post-market surveillance operation in the FDA. Important information can be learned about product safety after a device is on the market, and when there are problems, the sooner the response, the better.”
The senators say they recently sent “investigative letters” to five companies that recalled faulty medical devices requesting detailed information about how the companies conduct post-market surveillance and how the companies manage recalls when a product is pulled from the market. Letters were sent to Johnson & Johnson for its DePuy metal-on-metal hip implant; Medtronic for its Infuse product; Boston Scientific for Guidant's defibrillators; CR Bard for vaginal and hernia mesh products, and; Zimmer Holdings for its knee replacements.
Reacting to the bill, AdvaMed executive vice president Janet Trunzo said: “We believe expanding the FDA’s authority to require post-market studies as a condition of 510(k) clearance is unnecessary given the agency already has broad authority to require manufacturers to conduct post-market studies for higher-risk devices cleared via 510(k). Regarding the bill’s provisions to implement recent Government Accountability Office’s (GAO) recommendations to improve the FDA’s handling of medical device recalls, we believe, consistent with GAO recommendations, the FDA could do more to enhance the clarity and consistency of its recall process, and we are pleased that the agency has a number of initiatives underway in this area.”