Introduction to Medical Device Labeling

Posted on February 21, 2012. Filed under: Uncategorized |

Label vs. Labeling

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:
  • ‘display of written, printed, or graphic matter upon the immediate container of any article…’
    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:
  • ‘all labels and other written, printed, or graphic matter
    (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.”

Make a Comment

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )


Connecting to %s

Liked it here?
Why not try sites on the blogroll...

%d bloggers like this: