Risk of Recall Associated With Modifications to High-risk Medical Devices Approved Through US Food and Drug Administration Supplements.

ABSTRACT:

Importance

High-risk medical devices approved by the US Food and Drug Administration (FDA) can undergo modifications to their original premarket approval (PMA) via 1 of 5 types of supplements. Only panel track supplements (approximately 1%) require clinical data for approval. The association between device modifications and risk to patient safety has not previously been analyzed.

Objective

To determine the association between PMA supplements and the risk of any device recall and high-risk (class 1) recall.

Design, setting, and participants

In this cohort study, the FDA database was queried for original devices approved via PMA from January 1, 2008, through December 31, 2019. Supplement and recall data were obtained for these devices from January 1, 2008, through Decem

SUBMITTER: Dubin JR 

PROVIDER: S-EPMC10099049 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature