FDA Extends UDI Compliance Date for Certain Orthopaedic Implants

Effective immediately, FDA’s Center for Devices and Radiological Health (CDRH) is granting an extended compliance date for the Unique Device Identification System labeling requirements to September 24, 2016, for medical devices that are:

• classified with certain specific primary product codes and regulations
• single use implants
• intended to be sterilized (or cleaned and sterilized) before use

As noted by FDA, the additional time is intended to allow affected labelers to develop and implement approaches that will help ensure that the UDI is available at the point of use. Some affected labelers may have already implemented the UDI label and date format requirements for these devices. In such cases, this extension would only apply to the requirement to convey the UDI to point of use/implantation.

Compliance dates for the requirement to submit information to the Global Unique Device Identification Database (GUDID) under 21 CFR 830 subpart E are not extended, and remain September 24, 2015 for implantable devices that are Class II, Class I or unclassified.

Devices addressed in the extension include a variety of fixation screws, plates, staples and nails, as well as certain spinal devices. The entire list is available in FDA’s letter online.

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