what is FDA-cleared certificate?

1 Answer

  • Anonymous
    1 decade ago
    Favorite Answer

    The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food (humans and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal) and radiation emitting devices (including non-medical devices), biologics, and blood products in the United States.

    FDA Cearance and certification -

    The FDA derives its authority and jurisdiction from various Congressional acts. The main source of the FDA's authority is the Federal Food, Drug, and Cosmetic Act. Additionally, as a Federal agency, the FDA is required by Executive orders 13132 to review all proposed new rules for Federalism issues.

    The main purpose of the FDA is to protect citizens from products that are inherently unsafe or that make claims of effectiveness that cannot be substantiated. Because of the vast number of products or substances that may affect the public and the expertise required to evaluate them, Congress delegates this task to a specilized administrative agency.

    The FDA thus has the power to regulate a multitude of products in a manner that ensures the safety of the American public and the effectiveness of marketed food, medical, and cosmetic products. Regulations may take several forms, including but not limited to outright ban, controlled distribution, and controlled marketing. Additionally, the FDA sets the standards under which individuals may be licensed to prescribe drugs or other medical devices. Regulatory enforcement is carried out by Consumer Safety Officers within the Office of Regulatory Affairs and criminal matters are handled by special agents within the Office of Criminal Investigations (OCI)-.

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