UDI Working Group
Industry is faced with myriad well-intentioned rules and regulations that may prove impractical or even burdensome. The AIM NA Unique Device Identification (UDI) Working Group was developed to address industry concerns with the FDA’s recent UDI proposed rule.
The UDI Working Group’s mission is to collect member input--including expertise, guidance and best practices on the use of AIDC (automatic identification and data capture) technologies--and comment on the FDA UDI proposed rule with recommendations for the final rule adoption. Developing and promoting technologically and economically sensible implementation models, the working group will address the need for interoperability with national and international unique device and unique item identification requirements, emphasizing both compatibility and affordability. The working group will also strive to educate constituents with information to facilitate a seamless adoption of UDI and SNI using AIDC methodologies. The goal is to create a forum for open discussion of industry and FDA adoption issues and to communicate the following information:
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Why UDI?
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What devices need to be marked?
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Defining Medical Devices
In the US, medical devices are sorted into three risk-based classes, defined by the intended use of the device and on indications for use.
Class I Class I devices do not support or sustain life, and include items such as tongue depressors, crutches or canes, and hand-held surgical instruments. Class II Class II devices require more specialized controls than Class I devices, but can be used without causing injury or harm to patient or user. Class II devices include blood pressure cuffs, oximeters, and diagnostic x-ray systems. Class III Class III devices support or sustain life, or are integral to the prevention and or treatment of illness or injury, requiring significant controls to ensure safety. They include items such as prosthetic joint implants, cardiac pacemakers, and HIV diagnostic tests.
Timelines The FDA published the Final Rule in September, 2013 Class III
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