UDI Deadlines Extended for Some Devices

The FDA wants to avoid potential manufacturing disruptions.

In an effort to avoid disrupting access to medical devices, the FDA is extending deadlines for some unique device identifier requirements, according to Regulatory Focus.

According to the article, the FDA will not "enforce a statutory prohibition on National Health Related Item Code or National Drug Code numbers for device labels and packaging for certain devices manufactured prior to 24 September 2018 until 24 September 2021."

This specifically includes finished class III devices, devices listed under the Public Health Service Act, class II devices and implantable, life-supporting, or life-sustaining devices.

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