FDA Unique Device Identification Requirement for Medical Devices
On September 24, 2013, the U.S. Food and Drug Administration(FDA) announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI.
UDI Regulation Overview
Medical Device manufacturer companies have to create and maintain the Unique Device Identifier (UDI) which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.
UDI will be a unique numeric or alphanumeric code consisting of two parts, DI – identifies the labeler and the specific version or model of the device and PI – variable portion of UDI which is combination of lot/batch number, serial number etc.
UDI Implementation Timelines
The implementation timelines for UDI are based on the level of risk the medical device has, starting from Class III, Sept, 2014 to Class I in coming years. However, many low-risk medical devices will be exempt from some or all of the requirements of the Final Rule
Freyr Roadmap to UDI Compliance
Keeping the timelines in mind, Freyr offers a well-defined roadmap to fast-track UDI compliance comprising of a 3-step process. This process signifies Freyr’s dedication to assist and support medical device companies to attain industry compliance.
Global Unique Device Identification Data base (GUDID)
The GUDID serves as the repository of key device identification information which can be accessible by public. The DI serves as the primary key to obtain device information in database.
- 2 – 4 Week UDI Readiness Assessment
- Complete GAP Analysis to meet project’s objectives and timelines
- Developing an effective roadmap for UDI implementation
- Adept Data Management (collection, collation, validation and conversion)
- A 21 CFR Part 11 compliant ready-to-deploy UDI Software solution for effective Data Management and fast-track UDI compliance
- Preparation and UDI Submission Status Reports
- A robust, agile and scalable UDI system to manage complex submissions
- Support for current and future submissions with 360° lifecycle maintenance
- Centralized repository for audit requests and regulatory submissions
- Creating validated HL7 SPL Submission Packages, 21 CFR Part 11 compliant
Freyr IDENTITY leverages the Plan, Process and Training methodology to offer an end-to-end UDI compliance solution.
Suitable for a company of any size with any number of devices, Freyr IDENTITY is exclusively designed to streamline the complete compliance process by connecting disparate internal functions and integrating data sources and formatted information with a centralized database for automated XML generation and submission that meets all the FDA regulated UDI mandates.
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