In our first article on Unique Device Identification (UDI  we noted the UDI compliance deadlines set by the FDA that are staged over a span of six years, from September 24, 2014 to September 24, 2020. Each implementation date is dependent on several variables, including the device classification and whether or not the device is considered implantable, life-supporting or life-sustaining.

In order to comply with UDI deadlines, it is crucial to create a quality plan, particularly for those who label more than one device type or classification, which may lead to different deadlines1.

quality plan
A quality plan for UDI implementation should assess:

  • Compliance dates for each device
  • How to address UDI gaps within quality management system
  • Plans for updating or creating UDI labels
  • Process(es) needed for UDI direct marking
  • Verification and validation activities
  • FDA’s GUDID submission method
  • Regulatory filings needed
  • Risk management updates

 

Fulfilling the UDI regulations over an entire product portfolio can be a complex endeavor. A thorough quality plan can help ensure you have allocated the proper resources and provide a roadmap to meet deadlines. If you need assistance developing a quality plan for UDI, please call 512-328-9404 or contact us at info@qaconsultinginc.com.

1The table below provides a synopsis of the UDI compliance dates. Read the detailed requirements on the FDA’s website.

UDI compliance date table