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Vol. 77 Tuesday, No. 132 July 10, 2012, Part III Department of Health and Human Services mstockstill on DSK4VPTVN1PROD with PROPOSALS3 Food and Drug Administration 21 CFR Parts 16, 801, 803, et al.
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What is unique device identification system?
The unique device identification system is a system that assigns a unique identifier to medical devices to enhance their traceability and improve patient safety.
Who is required to file unique device identification system?
Manufacturers of medical devices are required to file the unique device identification system.
How to fill out unique device identification system?
The unique device identification system can be filled out online through the designated regulatory agency's website. It requires providing relevant information about the medical device, its manufacturer, and other details as per the regulatory guidelines.
What is the purpose of unique device identification system?
The purpose of the unique device identification system is to improve patient safety, enhance device traceability, facilitate device recalls, and improve post-market surveillance of medical devices.
What information must be reported on unique device identification system?
The unique device identification system requires reporting information such as device identifier, production identifier, version or model number, and the device manufacturer's name and contact details.
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