UDI Extension for Some Implantable Devices – What You Need to Know

The FDA granted a one year extension for some of the UDI requirements for some implantable medical devices. Find out what devices qualify for the extension, what requirements are extended and what compliance challenges some implantable device manufacturers are facing and how to overcome the obstacles.

The discussion will include:

  • Overview of the extension
  • What devices qualify for extension
  • What requirements are extended
  • Compliance challenges
  • Q & A session

About the Presenter:

Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system. At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry.

Register Now

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
See all Testimonials