FDA Extends UDI Compliance for Certain Class II Devices

By Michael Mezher – September 7, 2016

The US Food and Drug Administration (FDA) is giving medical device labelers two more years to comply with unique device identifier (UDI) requirements for certain Class II devices.

In a letter to device labelers dated Tuesday, FDA said it is extending the UDI compliance dates for so-called device convenience kits and repackaged single-use devices and is clarifying the compliance date for device constituents for certain combination products.

Under the UDI rule, FDA established a phased, risk-based approach to UDIs, which are tracking tags used to improve the safety of medical devices. The rule began applying to Class III devices in 2014 and implantable, life-supporting and life-sustaining devices in 2015. Class II devices, other than those listed in Tuesday’s letter, will need to comply later this month.

Since issuing the final rule in 2013, FDA has pushed back UDI compliance dates for certain products, such as Class III contact lenses and number of different orthopedic implants. Last week, FDA announced it would delay enforcement of another UDI provision that would require device makers to remove National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers from their devices by 24 September 2018 by three years.

Class II UDI Compliance

Now, FDA says it is extending the compliance date for certain Class II devices from 24 September 2016 to 24 September 2018, giving manufacturers two more years to meet UDI requirements for the affected products.



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Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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