FDA Proposes Medical Device Labeling

By May 10, 2013Medical Malpractice

The Food and Drug Administration (FDA) recently published the Proposed Rule: Use of Certain Symbols in Labeling in which it is proposing that the medical device and biological product labeling regulations be revised to explicitly allow internationally recognized stand-alone symbols that are explained in an accompanying symbols glossary.

This symbols glossary would include a list of each symbol, which is used in the medical device labeling, and an explanation of its meaning. The authorized symbols would be those recognized by a standards development organization such as the American National Standards Institute and the International Organization for Standardization.

Currently, stand-alone symbols are generally not allowed to be placed on medical device labeling here in the United States. Under FDA regulations any graphics or symbols in medical device labeling must be accompanied by its explanatory text next to the symbol. The FDA believe that this proposed change would help harmonize the European and U.S. regulatory requirements which currently force manufacturers to provide different labels for each market.

The Food and Drug Administration has also proposed that its prescription medical device labeling regulations also be revised to permit the use of the symbol “Rx only” without the inclusion of explanatory text on the labeling of prescription devices.

Under these new regulations, the FDA would expressly allow but not require the use of stand-alone symbols contained in a standard that the FDA recognizes under its authority under section 514(c) of the Federal Food, Drug and Cosmetic Act. Devices on which stand-alone symbols are used would have to be accompanied by a symbols glossary which lists each symbol used in the labeling of the device as well as the meaning for the symbol.

The FDA expects to evaluate standardized symbols over time and maintain a current list of recognized symbols on its Web site. The FDA is also encouraging comments on the proposed rule to be made no later than June 18.

3 Comments

  • Sounds like it could really simplify things internationally. That’s always good.

  • Under current FDA regulations, graphics, pictures or symbols in medical device labeling that represent required information must be accompanied by explanatory English text adjacent to the symbol. The FDA is now proposing to expressly allow (but not require) the use in such labeling without adjacent explanatory text of symbols contained in a standard that the FDA recognizes under its authority under section 514(c) of the Federal Food, Drug and Cosmetic Act. Devices on which such symbols are used would have to be contemporaneously accompanied by a “symbols glossary” that lists each symbol used in the labeling of the device as well as the meaning or explanatory text for the symbol.

  • 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).

Leave a Reply