The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Unique Device Identification: Direct Marking of Devices.'' Direct marking is an important feature of FDA's unique device identification system. This document is intended to assist industry and FDA staff to understand FDA's requirements for direct marking of devices with a unique device identifier (UDI). In addition, FDA is seeking information on what processes should be considered to meet the definition of ``reprocessing'' for purposes of UDI direct marking requirements.
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Unique Device Identification: Direct Marking of Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Unique Device Identification: Direct Marking of Devices.'' Direct marking ...
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80 FR 36821
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“Unique Device Identification: Direct Marking of Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability and Request for Comments,” thefederalregister.org (June 26, 2015), https://thefederalregister.org/documents/2015-15719/unique-device-identification-direct-marking-of-devices-draft-guidance-for-industry-and-food-and-drug-administration-staf.