PubMed

美国医疗设备监管史和当前监管框架

PMID：42296228 · 2026-06-15

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期刊JBJS reviews

年份2026-06-15

PMID42296228

摘要

» The Food and Drug Administration (FDA) was created in the wake of public outcry generated by Upton Sinclair's The Jungle. The FDA gained further regulatory authority following successive public health setbacks in the 20th century. » A full review for a new device is referred to as a premarket approval (PMA), while an application for a device based on a predicate is referred to as a premarket notification (PMN) better known as a 510k. » Both for PMNs and PMAs the costs and timelines typically f

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