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FDA Final Rule: Using Symbols on Medical Device Labels

Melvin G. Fletcher

III ISO 13485, CMDR, and MDD/CE Marking Certified Lead Auditor ICON Regulatory Services

The Food and Drug Administration (FDA) issued a final rule, entitled “Use of Symbols in Labeling” to harmonize the requirements of U.S. and international regulatory bodies and recognizes their standards for stand-alone symbols on medical devices and certain biological products. This rule will go into effect on September 13th, 2016.

The rule allows the use of stand-alone symbols in medical device labeling without adjacent explanatory text, as long as they are accompanied by a symbol glossary. While not included in this final rule, the FDA will also be revising its prescription device labeling regulations to allow the use of the symbol statement “Rx only” or “℞ only” on prescription device labels.

All stand-alone symbols must comply with other pre-existing labeling requirements in the FD&C Act, including section 502(a) and section 502(f), as well as relevant regulations such as 21 CFR Part 801.

Updated standards recognition notice

The FDA also published a new standards-recognition notice that modifies the current list of standards (Recognized Standards, Recognition List Number: 042). This notice extends the list of recognised standards from six to nine, thereby vastly increasing the number of accepted stand-alone symbols. An electronic copy of the Recognized Standards is available here.

Modifications to the Recognised Standards, Recognition List Number: 042 include the following.

In table 1, the FDA describes three modifications to their list of standards:

  • The withdrawal and replacement of standards (if applicable)
  • The correction of errors made by the FDA in their previous list of recognized standards
  • Changes to the supplementary information sheets for recognized standards that describe revisions to the applicability of the standards

In section III, the FDA lists additional standards not previously recognized by the FDA.

In table 2, the FDA lists new entries and consensus standards to the list of recognised standards under Recognition List Number: 042

For reference, you can access Guidance on the Recognition and Use of Consensus Standards and the searchable database for FDA Recognised Consensus Standards.

Implementation

If you need any assistance with implementing this new rule once it has been accepted, please contact ICON at for more information.

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