FDA Modifies Medical Device Labeling Requirements

After years of requiring most device manufacturers (besides IVD) to spell out the meaning of symbols within their labeling, FDA has issued a final rule that “allows the use of stand-alone symbols in medical devices without adjacent explanatory text”.

Previously, harmonized symbols recognized globally, such as “2” with a circle around it and slash through it (think “no smoking” symbol with a 2 instead of a cigarette), technically were required to have the text “Do not reuse” in English after it, when being distributed in the U.S.

Globally, this adjacent explanatory text often requires translation to a plethora of languages. Removal of English ‘adjacent text’ requirement eliminates these translation needs and aligns FDA requirements with global standards that allow for the use of symbols only. Moves such as this harmonize regulatory requirements and simplify the global regulatory landscape for manufacturers.

Here is a link to the FDA Final Rule on this matter where additional labeling modifications can be found: https://www.gpo.gov/fdsys/pkg/FR-2016-06-15/html/2016-13989.htm


If you have any questions on this article, do not hesitate to reach out via email to Robin Martin at Kinetic Compliance Solutions, LLC TM: robinmartin@kineticcompliance.com.  Kinetic Compliance Solutions, LLC partners with companies to provide legal and regulatory consulting solutions in the highly regulated medical device and life sciences industries.

This article represents the author’s views based on experience, in addition to publicly available information.   Content in this article is not intended to be legal advice.

By | 2017-08-08T21:57:16+00:00 June 30th, 2016|Medical Device Information|