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Recorded Webinar

FDA Medical Device Regulation - Unique Device Identifier Requirements

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule, starting September 2014. To be fully prepared, you need to understand what UDI is, who it applies to, what the exceptions to the rule are, what deadlines you must meet, who/what UDI issuing agencies are, and how to work with them.

The presentation will cover the following areas:

  • The difference between UDI and traceability and device tracking
  • The timetable for implementation for Class I, Class II and Class III devices
  • Which devices must comply with the rule and which are exempt
  • What information must be included on product labels
  • How to submit device identification information to the GUDID
  • About the accredited UDI issuing agencies, and their role in UDI
  • The benefits of UDI to industry, regulators and the public


Apply for this webinar

Who should attend

Anyone who is involved in labeling activities, especially marketing, production, regulatory/quality

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