News International

US FDA extends the UDI compliance dates

Posted on 30.06.2017

US FDA UDI compliance deadlines covering labelling, GUDID submission, and standard date formatting requirements for Class I low-risk medical devices have been extended to 24 September 2020. Direct UDI marking requirements for the same low-risk devices will be applicable as of 24 September 2022.

The new deadlines do not apply to Class I or unclassified devices that are implantable, life-supporting or life-sustaining, because labelers of these devices must already be in compliance with UDI requirements (the compliance date was 24 September 2015).

The FDA plans to issue new guidance covering enforcement discretion for low-risk medical device UDI labelling, GUDID submission, standard date formatting and direct mark obligations.

The extension is necessary for the FDA in order to fully standardize and optimize UDI data already collected on high-risk devices. UDI implementation for higher-risk devices has also created technical and policy challenges for both FDA regulators and registrants (until 1 May 2017, 1.4 million records have been submitted to the FDA’s Global Unique Device Identification Database, GUDID).

By extending UDI labelling timelines for low-risk devices will allow the agency to address and remedy these challenges before even more data is submitted to GUDID.

For more information, see US FDA’s Letter to Device Labelers on UDI Compliance Dates for Class I and Unclassified Devices – June 2, 2017.

MedTech Europe is positive that the learnings of the UDI implementation in the US will be taken into account by the European legislators when implementing the European UDI database.