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Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices. Final rule.

PMID: 29932613 · 2018-02-21

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학술지Federal register

연도2018-02-21

PMID29932613

초록

The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a

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