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Medical Devices Need Follow Up After U.S. Approval, Senators Say

U.S. regulators would gain greater authority to track the use of devices, such as hip implants from Johnson & Johnson and vaginal meshes made by Boston Scientific Corp., that have sparked thousands of patient lawsuits, under a bill introduced in the Senate.

Under the legislation, the Food and Drug Administration could order companies to conduct safety studies of devices after they’re approved and could grant conditional approvals pending the result of ongoing trials. That would strengthen rules for products approved through the so-called 510(k) system, which now requires companies only to show their devices are similar to those already on the market.