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:

Importance

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.

Objective

To determine the risk of a future Class I recall associated with using a recalled device as a predicate device in the 510(k) pathway.

Design and setting

In this cross-sectional study, all 510(k) devices subject to Class I recalls from January 2017 through December 2021 (index devices) were identified from the FDA's a

SUBMITTER: Kadakia KT 

PROVIDER: S-EPMC9857464 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature