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Contains Nonbinding RecommendationsUnique Device Identification System:
Small Entity Compliance Guide
Guidance for Industry and
Food and Drug Administration Staff
Document issued on August 13, 2014.
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How to fill out unique device identification system
How to fill out unique device identification system:
01
Gather all necessary information about the device: Before filling out the unique device identification system, make sure you have gathered all relevant information about the device. This may include details such as the device's manufacturer, model number, serial number, and any other identifying information.
02
Access the unique device identification system: Depending on the specific system being used, you may need to access it through a designated website or software. Ensure you have the necessary login credentials and permissions to access the system.
03
Enter the device information: Once you have accessed the unique device identification system, start by entering the required device information into the appropriate fields. This may include the device's unique identifier, production history, distribution information, and any other relevant details.
04
Verify the accuracy of the entered information: After entering the device information, take the time to review and verify the accuracy of the data. Double-check the details you have entered to ensure they are correct and complete.
05
Submit the information: Once you are confident that all the necessary device information has been accurately entered, proceed to submit the information. Follow any specific instructions provided by the unique device identification system to successfully complete the submission process.
Who needs unique device identification system:
01
Medical device manufacturers: Unique device identification systems are crucial for medical device manufacturers to comply with regulatory requirements. They need these systems to assign unique identifiers to each of their devices and maintain accurate records for traceability purposes.
02
Healthcare providers: Healthcare providers, including hospitals, clinics, and medical facilities, rely on unique device identification systems to efficiently track and manage medical devices within their operations. These systems help ensure patient safety, streamline inventory management, and facilitate device recalls or maintenance.
03
Regulatory agencies: Government regulatory agencies responsible for overseeing the safety and effectiveness of medical devices rely on unique device identification systems to monitor the market and identify potential risks associated with specific devices. These systems allow regulators to track device performance, investigate adverse events, and enforce compliance with industry regulations.
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What is unique device identification system?
Unique Device Identification (UDI) system is a method of labeling medical devices with unique codes to identify and track them throughout their distribution and use.
Who is required to file unique device identification system?
Manufacturers of medical devices are required to file unique device identification system.
How to fill out unique device identification system?
Unique device identification system can be filled out electronically using the FDA's Global Unique Device Identification Database (GUDID).
What is the purpose of unique device identification system?
The purpose of unique device identification system is to improve patient safety by facilitating the tracking and tracing of medical devices.
What information must be reported on unique device identification system?
The unique device identification system requires reporting of device identifier, production identifier, expiration date, and other relevant information.
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