6th Annual UDI Conference October 2014

6th Annual UDI Conference October 2014

UDI Conference October 2014

The 6th Annual UDI Conference held in Baltimore, MD on October 28th and 29th was highlighted with the following takeaway points that may impact your business:

    • The prevailing belief that UDI system will ultimately benefit your company as well as your customers and stakeholders. It may help to decrease waste and increase safety and efficiency in the supply chain.

 

  • The FDA will be using a Phased Approach for compliance to the UDI Regulation based on the Classification of Devices. The compliance dates range from September 2014 through 2019. Check out the compliance dates through this link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
  • Compliance dates for revising the format of dates on the label to YYYY-MM-DD are the same as the above compliance dates per device class (Sept 2014 – 2019).
  • CFR changes will require updates to SOPs and Quality Manuals for Recalls, MDRs and more.

Those in attendance that represented Class III manufacturers shared their experiences to meet the September 24, 2014 UDI implementation.

  • “This process will take more time and effort than you think! Start now if you haven’t already.”
  • Create a multifunctional team to take on the long term project of UDI implementation. The system does not just affect the product label; it will affect Quality Systems, Regulatory Procedures, Product Development, and Business Practices.
  • Talk to your users (clinical staff and distributors) and stakeholders to create solutions that work.

Boston Biomedical Associates will be issuing a series of newsletters addressing the UDI system and the intricacies involved with implementation and maintenance. Stay tuned for more!

Follow us on twitter at @BBA_CRO or contact us for more information.

Mack Rubley
mrubley@boston-biomedical.com

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