医疗器械风险(再)分类:来自FDA 515计划倡议的教训

IF 2.1 Q2 SURGERY BMJ Surgery Interventions Health Technologies Pub Date : 2023-09-01 DOI:10.1136/bmjsit-2023-000186

Maryam Mooghali, Vinay K Rathi, Kushal T Kadakia, Joseph S Ross, Sanket S Dhruva

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摘要

#### 1976年对食品、药品和化妆品法案的医疗器械修正案授予美国食品和药物管理局(FDA)对医疗器械的监管权力。国会打算让FDA的审查要求与所需提供的信息量相对应。

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Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative

#### Key messages box The 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act granted the US Food and Drug Administration (FDA) regulatory authority over medical devices. Congress intended for FDA’s review requirements to correspond to the amount of information needed to provide ‘

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