FDA Revises Medical Device Labeling Restrictions | Practical Law

FDA Revises Medical Device Labeling Restrictions | Practical Law

The Food and Drug Administration (FDA) has issued a final rule to revise its medical device labeling requirements under the Food, Drug, and Cosmetic Act (FDCA). Under this rule, manufacturers can use symbols or graphical representations of information in labeling without including adjacent explanatory text if the manufacturer meets certain requirements.

FDA Revises Medical Device Labeling Restrictions

Practical Law Legal Update w-002-6674 (Approx. 4 pages)

FDA Revises Medical Device Labeling Restrictions

by Practical Law Commercial Transactions
Law stated as of 15 Jun 2016 • USA (National/Federal)
The Food and Drug Administration (FDA) has issued a final rule to revise its medical device labeling requirements under the Food, Drug, and Cosmetic Act (FDCA). Under this rule, manufacturers can use symbols or graphical representations of information in labeling without including adjacent explanatory text if the manufacturer meets certain requirements.
The Food and Drug Administration (FDA) issued a final rule on June 15, 2016, to revise its medical device labeling requirements under the Food, Drug, and Cosmetic Act (FDCA) by expanding how manufacturers can use symbols and graphical representations of information on labels (Use of Symbols in Labeling, 81 Fed. Reg. 38911-01 (June 15, 2016)).
Under the FDA's prior interpretation of its regulations, manufacturers could not use symbols in medical device labeling unless the symbols were either:
  • Adjacent to English-language explanatory text.
  • On in vitro diagnostic devices intended for professional use.
This final rule allows manufacturers to use symbols established in a standard developed by a standards development organization (SDO) in medical device labeling without including adjacent explanatory text. However, medical device manufacturers can only use these symbols without including adjacent explanatory text in their labels if either:
  • The FDA recognizes the standard under Section 514(c) of the FDCA (21 U.S.C. § 360d(c)) and the symbol is used according to the symbol's specifications for use outlined in the FDA's Section 514(c) recognition.
  • The device manufacturer:
    • determines that the ordinary individual is likely to read and understand the symbol under customary conditions of purchase and use; and
    • uses the symbol according to the symbol's specifications for use outlined in the SDO-developed standard.
This new rule also allows manufacturers to use the symbol statement "Rx only" or "[rx] only" for labeling prescription devices.
If a manufacturer takes advantage of this rule:
  • The manufacturer must explain the symbol in a paper or electronic symbols glossary that is included in the medical device's labeling.
  • The labeling on or within the package containing the device must bear a prominent and conspicuous statement identifying the location of the symbols glossary.
  • The use of the symbols must comply with other applicable FDCA labeling requirements (see Practice Note, Product Labeling: Food, Drugs, Medical Devices, and Cosmetics).
To clarify this rule's requirements, the FDA has included an illustrative example in the Federal Register notice (81 Fed. Reg. 38911-01, 38920). This rule becomes effective on September 13, 2016.
For more information on the FDA's requirements for labeling medical devices, see Practice Note, FDA Medical Devices Regulations: General Device Labeling Requirements.