Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003-2019.

Abstract

The US Food and Drug Administration (FDA) regulates the marketing of medical devices based on the premarket approval (PMA) or 510(k) pathway. We investigated the relationship among the regulatory pathway of otolaryngologic devices, the number of recalls, and the recall characteristics. Retrospective cross-sectional analysis. Publicly available FDA databases. The FDA Ear, Nose, and Throat Devices Panel database was queried for 510(k) clearances and PMA approvals from 1976 to 2019. Device recalls