Evidence on safety of implanted devices is often not publicly available, study findsBMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5923 (Published 30 September 2014) Cite this as: BMJ 2014;349:g5923
- Michael McCarthy
Researchers have been unable to find documentation of the scientific evidence used to allow hundreds of medical devices to be marketed in the United States, despite requirements that such information be publicly available.1
Each year the US Food and Drug Administration allows about 400 medical devices onto the market without clinical trials, provided the manufacturers submit scientific evidence that the new devices are “substantially equivalent” to devices previously cleared by the agency—known as “predicates”—in a process called 510(k) clearance.
Unlike drugs, which the FDA requires to undergo clinical trials to demonstrate their safety and effectiveness, only about 1% of medical devices are required to undergo such rigorous pre-approval testing. The FDA requires no testing for about two thirds of devices, such as crutches and scalpels, which the agency designates as “low risk.” The remainder—about one third of devices, designated as “moderate to high risk”—are “cleared …