In November 2017, FDA released their final guidance on unique device identifier (UDI) entitled, “Unique Device Identification: Direct Marking of Devices.” The guidance highlights the importance of direct marking for devices that undergo reprocessing, and the document provides further insight into the agency’s interpretation of the federal regulation.
The document re-emphasizes the importance of direct device markings on devices such as duendoscopes. The guidance also reinforces the significance of product labeling on primary and outer packaging of products. This adds additional regulatory emphasis on categories of multiuse devices, already under a microscope for product validations to define a device as clean .
WuXi AppTec recognizes the significance of validation work and safety testing to support a device preclinical submission or device record as part of a design history file.
WuXi AppTec provides regulatory, consulting services to support device manufacturers through gap analysis and test development strategies. Our technical expertise assists with not only device reprocessing validations but also packaging testing – package integrity and other physical tests, simulated distribution, and product stability and accelerated aging.
We work to support our customers with end-to-end preclinical device safety services from design through lifecycle management. As regulations continue to evolve, we look to collaborate with device manufacturers to ease the burden of preclinical safety testing through the validation process.
Contact us to learn more about our approach at firstname.lastname@example.org or 888-794-0077.