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  • Title: Medical devices; procedures for premarket notification, premarket approval, classification, performance standards establishment, banning devices, and availability of regulatory hearings--FDA. Final rule.
    Journal: Fed Regist; 1992 Dec 10; 57(238):58400-6. PubMed ID: 10123143.
    Abstract:
    The Food and Drug Administration (FDA) is amending the medical device regulations governing procedures for premarket notification, premarket approval, classification, performance standards development, banning devices, and availability of regulatory hearings to conform these procedures to applicable provisions of the Safe Medical Devices Act of 1990 (the SMDA). Its publication promotes clarity and certainty to regulated industry and thus fosters economic growth by correcting the provisions in FDA's existing regulations to conform them to the now-governing statutory provisions.
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