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  7. Labeling Requirements - Over-The-Counter (Non-Prescription) Medical Devices
  1. General Device Labeling Requirements

Labeling Requirements - Over-The-Counter (Non-Prescription) Medical Devices

Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals

Principal Display Panel 21 CFR 801.60

  • The principal display panel is that portion of the label which is intended to be displayed, presented, shown, or examined under customary conditions for retail sales. The area of the principal display panel is considered to be:
    • In the case of a rectangular package, the height x width of one side;
    • In the case of a cylindrical or nearly cylindrical package, 40% of height x circumference; or
    • In the case of any other shapes, 40% of the total surface area of the container, unless a more prominent site exists.

Statement of Identity 21 CFR 801.61

  • The statement of identity of the device must be listed on the principal display panel.
    • It must list the common name of the device followed by a statement of its principal intended action(s);
    • Indications for use must be listed in the directions for use; and
    • The statement must be in bold type, reasonably related in size to the most prominent printed matter on the display panel, and must be in lines generally parallel to the base of the package on which it rests.

Net Quantity of Contents Statement 21 CFR 801.62

  • The label of an over-the-counter (OTC) device in package form must contain a statement of net quantity of contents in terms of weight, measure, numerical count; or a combination of numerical count and weight, measure, or size, which are described below:
    • Count - If the declaration by count does not give accurate information as to the quantity, it shall be augmented by statements of weight, measure, or size;
    • Measure - In cases of established customer usage and trade custom where units of linear measure or measure of area are used, they shall be augmented when necessary with statements of weight measure or size. Liquid measure is to be expressed in terms of the U.S. gallon of 231 cu. In. And quart, ping, and fluid ounce subdivisions, and shall express the volume at 68 degrees Fahrenheit; and
    • Weight - Terms of weight are to be expressed in avoirdupois pound and ounce. Units of metric weight or measure are considered supplemental. The declaration may contain common or decimal fractions. Common fractions shall be reduced to their lowest terms.
    • Placement - The declaration shall appear as a separate item on each principal display panel; and be separated by at least a space equal to the height of the lettering used in the declaration, from other information appearing above and below, and separated by at least twice the width of the letter "N" from labeling to the left or right.


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