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Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls by Kushal T. Kadakia; Sanket S. Dhruva; César Caraballo; Joseph S. Ross; Harlan M. Krumholz is a Medicine article available to read on EtoBox.

What is Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls about?

## 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 annual recall listings. Information about predicate devices was extracted from the Devices@FDA database. Devices authorized using index devices as predicates (descendants) were identified using a regulatory intelligence platform. A matched cohort of predicates was constructed to assess the future recall risk from using a predicate device with a Class I recall. ## Main Outcomes and Measures Devices were characte

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

Author

Kushal T. Kadakia; Sanket S. Dhruva; César Caraballo; Joseph S. Ross; Harlan M. Krumholz

Publisher

American Medical Association (AMA)

Published

2023

Language

EN

Field

Medicine (Health Sciences)