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PubMed

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

PMID: 29932613 ·

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JournalFederal register
Year
PMID29932613

Abstract

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

Official Source

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Data sourced from PubMed / NCBI. For the full text and most current information, always refer to the official record.

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