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Study
Use of recalled devices in new device authorizations under the US Food and Drug Administration's 510(k) pathway and risk of subsequent recalls.
January 25, 2023
Kramer DB, Yeh RW. JAMA. 2023;329(2):136-143.
The Food and Drug Administration (FDA) plays an important role in ensuring the safety of medical devices. In this cross-sectional study, researchers identified a high risk of future Class 1 FDA recall (the most serious recall designation, indicating serious risks to patient safety) among previously authorized devices (predicates) with prior Class 1 recalls.
