udi – Duane Morris Life Sciences Law

July 26, 2021 by Duane Morris

FDA Issues Final Guidance on Form and Content of Unique Device Identifier Labeling System

On July 7, 2021, the U.S. Food and Drug Administration (FDA) issued a final guidance regarding the form and content of unique device identifier (UDI) labeling. The guidance will assist labelers of medical devices and FDA-accredited issuing agencies (who operate systems for issuing UDIs used by labelers) in meeting the requirements under 21 CFR Part 801, Subpart B, and the Unique Device Identification System Final Rule, 78 FR 58786 (September 24, 2013) (UDI Rule).

To read the full text of this Duane Morris Alert, please visit the firm website.

December 27, 2018 by Duane Morris

FDA Announces New UDI Compliance Deadlines via Another Guidance Document

On September 24, 2013, the Food and Drug Administration (FDA) issued a “final” rule regarding the Unique Device Identification System to adequately identify devices through distribution and use. The FDA has since issued several guidances updating implementation of the unique device identifier (UDI). On November 5, 2018, the FDA issued its latest UDI policy, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” which supersedes the direct marking deadlines mandated by an earlier guidance.

Read the full Alert on the Duane Morris website.