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Marketing Unique Device Identifiers

Morgan Lewis

FDA Extends UDI and Direct Marking Enforcement Discretion for Class I and Unclassified Devices to 2022

Morgan Lewis on

The US Food and Drug Administration’s recent policy, issued in part due to the coronavirus (COVID-19) pandemic, also suspends enforcement of Direct Marking requirements for certain Class I, Class II, Class III, and...more

Morgan Lewis

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

Morgan Lewis on

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

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