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眼科機器の初回食品医薬品局（FDA）市場承認後のライフサイクルにおける逐次改訂，1979-2015

PMID: 28501378 · 2017-05-10

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学術誌Ophthalmology

年2017-05-10

PMID28501378

抄録

To characterize the frequency, nature, and regulatory mechanisms by which ophthalmic devices are iteratively modified after initial Food and Drug Administration (FDA) Premarket Approval (PMA). Retrospective cross-sectional analysis using publicly available FDA data. Ophthalmic devices initially approved via the FDA's PMA pathway between January 1, 1979 and December 31, 2015. We used the FDA's PMA Database to identify and characterize initial approvals and subsequent postmarket modifications to C

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