The Medical Device Manufacturer's Quick Reference Guide to UDI
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The document outlines the requirements for Unique Device Identification (UDI) mandated by the FDA for medical devices, highlighting the importance of UDI in addressing adverse events and recalls. It specifies that every medical device must include a UDI on its label and in machine-readable formats, along with compliance deadlines and penalties for non-compliance. Manufacturers must provide identifying information to the FDA’s Global Unique Device Identification Database (GUDID) to sell their products in the U.S.
The Medical Device Manufacturer's Quick Reference Guide to UDI
- 1. Make Sure You Have the Right Software. The Medical Device Manufacturer’s Unique Device Identification UDI Quick Reference Guide to Why is UDI required? 50,000 serious adverse events related to medical devices are estimated by the FDA to be reported each year 3,000 deaths are estimated to result Medical device recalls have doubled in the last decade. What is a UDI? A unique numeric or alphanumeric code that includes: A device identifier (DI), which is specific to a device model A production identifier (PI), which includes the current production information for that specific device, such as lot or batch number, serial number, expiration date or a combination. The FDA’s 5 Main Requirements The label of every medical device must have a UDI. Assign a globally unique, standardized identifier to devices. The UDI must appear on the label in a human readable format, plus in a format that can be read by automatic identification and data capture (AIDC) technology. Directly mark the UDI on the device itself if the device is intended to be reused and reprocessed. Provide identifying information to FDA’s GUDID database for others to access and use. Where do we get the UDI number? What date convention should we use? What are the penalties for Three Issuing Agencies (IA) currently accredited by the FDA assign the Device Identifier portion of the UDI. The UDI rule requires the ISO standard “YYYY-MM-DD” date format on the label. Manufacturers will not be able to sell their product in the US if it is not labeled and uploaded to the FDA’s GUDID. Potential enforcement actions include seizure, injunction, civil and criminal penalties. Compliance Dates for UDI Requirements By September 24: Classification: Labels and packages of implantable, life-supporting, and life-sustaining devices Class III devices* required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself. Labels and packages of class II medical devices Class II devices* required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself. Labels and packages of class I medical devices and devices not classified into class I, class II, or class III Class I devices*, and devices* not classified into class I, class II, or class III, must bear UDI as a permanent marking on the device itself. 2015 2016 2018 2020 ? noncompliance? * If intended to be used more than once and to be reprocessed before each use Will Your Company Be Ready? Contact Us Today For Your Best Options A leading software consulting firm since 1980. (949) 583-9500 Blytheco.com. Sources http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ CompliancedatesforUDIRequirements/default.htm http://duvalfdalaw.com/docs/udi_white_paper.pdf http://www.emergogroup.com/blog/2015/04/udi-here-seven-things-you-need-know http://www.gs1us.org/industries/healthcare/gs1-healthcare-us-initative/fda-udi Each of the items below are required to bear a UDI and the appropriate data must be submitted to the GUDID database.