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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
The U.S. Food and Drug Administration (FDA) develops and administers
regulations under authority granted by laws passed by Congress that apply to
food, drugs, cosmetics, biologics, radiation-emitting electronic products, and
medical devices. Labeling regulations pertaining to medical devices are found
in the following Parts of Title 21 of the Code of Federal Regulations (CFR).
General Device Labeling - In Vitro Diagnostic Products - Investigational Device Exemptions - Good Manufacturing Practices - General Electronic Products - |
The Federal Food, Drug and Cosmetic Act (FFDCA) is the law under which the
FDA takes action against regulated products. Specifically:
Section 201(k) defines "label" as a:
The term "immediate container" does not include package liners.
Any word, statement, or other information appearing on the immediate container
must also appear "on the outside container or wrapper, if any there
be, of the retain package of such article, or is easily legible through
the outside container of wrapper."
Section 201(m) defines "labeling" as:
(1) upon any article or any of its containers or wrappers, or
(2) accompanying such article" at any time while a device is held
for sale after shipment or delivery for shipment in interstate commerce.
The term "accompanying" is interpreted liberally to mean more
than physical association with the product. It extends to posters, tags,
pamphlets, circulars, booklets, brochures, instruction books, direction
sheets, fillers, etc. "Accompanying" also includes labeling that
is brought together with the device after shipment or delivery for shipment
in interstate commerce.
According to an appellate court decision: "Most, if not all advertising, is labeling. The term 'labeling' is defined in the FFDCA as including all printed matter accompanying any article. Congress did not, and we cannot, exclude from the definition printed matter which constitutes advertising."
Natural Rubber (Latex) Labeling
Updated April 24, 2003
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