Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.

Abstract

In the US, nearly all medical devices progress to market under the 510(k) pathway, which uses previously authorized devices (predicates) to support new authorizations. Current regulations permit manufacturers to use devices subject to a Class I recall-the FDA's most serious designation indicating a high probability of adverse health consequences or death-as predicates for new devices. The consequences for patient safety are not known. To determine the risk of a future Class I recall associated w