FDA Delays UDI Requirements for Low-Risk Devices

Rollout of FDA’s UDI rule has been fraught with challenges.  Since issuing the final UDI rule in 2013, FDA has pushed back compliance dates for a number of devices in response to concerns from companies over meeting deadlines or to address specific technical challenges.  However, UDI requirements are already in effect for many higher-risk devices, including Class III, implantable and life-supporting/life-sustaining devices such as artificial heart valves and automated external defibrillators (AEDs).  And, FDA says its Global UDI Database contains 1.4 million records submitted by more than 4,000 device labelers.

Extension for Class I/Unclassified Devices

FDA says it is extending the requirements for Class I and unclassified devices to bear a UDI on their labels and packages, as well as the requirement for those devices to submit data to GUDID, from 24 September 2018 to 24 September 2020.  The Agency is also delaying the direct mark requirement for Class I and unclassified devices, which requires devices to bear a UDI on the device itself if the device is reusable and must be reprocessed before each use, from 24 September 2020 to 24 September 2022.

FDA says it is delaying the requirements in order to work out some of the challenges related to UDI for higher-risk devices before the influx of lower-risk devices enter the system, and in response to concerns from industry about meeting the compliance dates.  “We identified complex policy and technical issues that need resolution, such as how UDI applies to products such as medical procedure trays that contain implantable devices and instruments. Providing accurate and timely support to labelers has also been challenging, due to the sheer number and wide diversity of devices,” FDA writes.

Going forward, FDA says it is planning to issue a guidance document to detail its enforcement discretion policy for labeling, GUDID data submission, standard date formatting and direct mark requirements for the affected devices.

REFERENCE:  RAPS Regulatory Focus; 05 JUN 2017; Michael Mezher

Leave a Comment