While the goal was for FDA to develop the proposed Unique Identification Rule in close collaboration with the clinical community, patient and consumer groups, and with the data from four pilot studies- is it possible FDA missed the mark? According to the industry group The Advanced Medical Technology Association (AdvaMed) changes need to be made to the agency’s rule to make it useful, cost-effective and practical.
Significant changes to the proposed rule suggested by AdvaMed, as listed on their website’s press-release include the following points:
- Manufacturers of Class III devices should be given two years after the final UDI rule is issued to comply with the rule’s labeling requirements, instead of one year.
- FDA should develop a specific list of devices exempt from UDI direct marking requirements, such as absorbable sutures or stents, because such devices cannot be directly marked.
- FDA should clarify that devices manufactured before the final UDI rule’s effective date but held in inventory are not subject to the rule.
Not all of the press-release was bad news. In fact, AdvaMed did commend FDA on its risked-based approach to implementing the system for medical devices. Also, it’s important to note FDA has a wide range of information available on their website which explains the system, but also lists out the expected benefits, including:
• Improvements to adverse event reporting
• Reduction in medical errors
• Enhancements to analysis of approved devices
• Standardization of identifiers to manage recalls
- UDI Piloting Activities
- UDI Related Trainings, Papers, Reports
- UDI Public Meetings and Notices
It seems FDA is trying to be clear on the new rule, what to expect, and hopefully what is to gain from the new system. However; industry seems to have a clear voice in the matter too and rightfully so! As the VP of AdvaMed said, this could be “the most extensive and complex FDA regulation to be issued in recent memory.” Check out the detailed comments from AdvaMed’s review of UDI.
What are your thoughts on the system? Do you think more changes are needed to ensure FDA implements the new rule correctly from the start? Share your concerns below.
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