May 27, 2020

May 27, 2020

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May 26, 2020

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FDA Extends Unique Device Identification (UDI) System Compliance Deadlines for Certain Low-Risk Medical Devices

On June 2, 2017, the US Food and Drug Administration (FDA) announced that it plans to delay the dates by which certain Class I devices and unclassified devices must comply with the agency’s unique device identification (UDI) system requirements. Previously, FDA was scheduled to begin enforcement of the UDI system requirements for regulatory labeling, Global Unique Device Identification Database (GUDID) data submission and date formatting on September 24, 2018, and direct mark requirements on September 24, 2020, for Class I devices and unclassified devices that are not implantable, life-supporting or life-sustaining. In the announcement, FDA indicated that it intends to issue a guidance document that will provide enforcement discretion for two additional years beyond the current deadlines (i.e., until September 24, 2020, and September 24, 2022, respectively). The agency intends to exercise enforcement discretion with respect to these devices so that agency can focus on issues related to the integration of the UDI for higher-risk devices into electronic health records throughout the health care system.

This is not the first time that FDA has issued a letter to device labelers extending the UDI enforcement dates for certain devices, which were initially established in a 2013 final rule. The final rule set different effective dates for different classes of devices, with higher risk devices (e.g., Class III devices) required to come into compliance first. In the June 2 letter, FDA is not changing the deadline for labelers of the higher-risk devices that currently must comply with the final rule.

Low-risk and unclassified device labelers are likely to welcome the extension, particularly insofar as they supported industry’s efforts to obtain an extension from FDA, and should monitor communications from the agency to confirm the release of the guidance referenced in the letter. In the interim, device labelers should continue to submit inquiries regarding alternatives to or requests for exemptions from UDI requirements, if applicable.

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Vernessa Pollard Pharmaceutical Attorney McDermott

    Vernessa T. Pollard is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C., office. Vernessa serves as co-head of the Firm’s Food and Drug Administration (FDA) practice.

    Vernessa advises companies on regulatory, compliance, enforcement and legislative matters involving pharmaceuticals, medical devices, digital and mobile health, health IT solutions and services, and emerging technologies and software. She also advises national and international food and cosmetic producers and retailers on...

    Michael Ryan Attorney specializing in Pharma law McDermott Law Firm

    Michael W. Ryan is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.

    Michael focuses his practice on the legal, regulatory and reimbursement issues that manufacturers and investors encounter in the development and commercialization of pharmaceuticals, medical devices, biotechnology products and laboratory services.  Michael counsels entities as they seek to obtain authorization to market their products from the U.S. Food and Drug Administration, maintain compliance with applicable laws and regulations (including the...

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    Vanessa K. Burrows is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C., office.  She focuses her practice on health care law, with an emphasis on medical device, food and drug, and pharmacy law. Her broad-based experience also includes HIPAA compliance, health privacy and security laws, and public health law. She advises health care entities and their contractors on compliance, regulatory, data-sharing, licensing, and enforcement matters.

    Previously, Vanessa served as the HIPAA Privacy...

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