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  • Title: Postmarket surveillance. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2002 Jun 06; 67(109):38878-92. PubMed ID: 12053947.
    Abstract:
    The Food and Drug Administration (FDA) is implementing the postmarket surveillance (PS) provisions of the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The purpose of this rule is to provide for the collection of useful data about devices that can reveal unforeseen adverse events or other information necessary to protect the public health.
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