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Orthopaedic Industry News & Orthopaedic Company News | Orthogate Professionals

Details
By mwood@beckershealthcare.com (Megan Wood)
mwood@beckershealthcare.com (Megan Wood)
Industry News
06 September 2016

FDA grants 2-year extension for some Class II devices to meet UDI compliance: 5 key notes

Here are five key notes:

1. The FDA extended the UDI compliance deadline for device convenience kits and repackaged single-use devices.

2. Companies had to implement UDI compliance for Class III devices in 2014 and for implantable, life-supporting and life-sustaining devices in 2015.

3. All Class II devices not mentioned in the FDA's extension must comply with UDI standards by Sept. 24, 2016.

4. The FDA extended the compliance for the devices with different formats and packaging than the other Class II devices.

Visit Original Source

Last Updated: 06 September 2016
Previous article: 4 key takeaways on the Asia-Pacific spine surgery devices market; key leaders include Stryker, NuVasive & more Prev Next article: Orthopedic industry booming in Warsaw Next
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