Latest questions:
Trending questions:
Hot questions:
UDI Direct Marking of Devices
In lieu of the FDA draft guidance for the unique device identification direct marking of devices, what is the definition of "permanent" and how can it best be validated for devices intended to be used more than once and intended to be reprocessed before each use?
83 months ago
2 answers
FDA has provided an answer to this question: " Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants deliver medication, monitor body functions, or provide support to organs and tissues.
Some implants are made from skin, bone or other body tissues. Others are made from metal, plastic, ceramic or other materials.
Implants can be placed permanently or they can be removed once they are no longer needed. For example, stents or hip implants are intended to be permanent. But chemotherapy ports or screws to repair broken bones can be removed when they no longer needed."
Hence, whether the device is permanent or not is determined by its the INTENDED USE.
83 months ago
I fully agree with the answer above. In addition, to answer your question of marking, I assume that it is needed in such cases to add special characters to the marking identification in order to assess the number of reprocessing when the device is intended to be reprocessed before reuse.
83 months ago
