All these patients, it turned out, had a small device implanted in the top of their spines to relieve pain. Safety problems have led to recalls of devices implanted in hundreds of thousands of people. In 1976, when medical devices first came under the regulatory control of the FDA, the agency simply grandfathered in all devices that were already on the market. But the agency also lets higher-risk devices through based on predicate devices, some of which have been recalled for safety problems. First, the FDA should recategorize any implanted device as a high-risk or Class III product, which would subject it to rigorous clinical trials.

Source: Washington Post January 04, 2019 15:43 UTC