FDA issues draft guidance on medical device marking

June 29, 2015 – On June 26, 2015, the U.S. Food and Drug Administration (FDA) issued a new draft guidance document entitled: “Unique Device Identification: Direct Marking of Devices,” which will assist industry and FDA staff with understanding the requirements for direct marking of devices for unique device identification purposes.  The draft guidance defines some terms used in the FDA’s regulations relating to the marking requirements.

Related: FDA Launches New Database for Medical Devices (May 12, 2015)

By: Frederick C. Millett

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