U.S. FDA Releases Class I and Unclassified Medical Device Compliance Date Guidance

16/01/18

Event Title

08h00 - 16h30

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The U.S. Food and Drug Administration (FDA) recently published the guidance, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices Immediately in Effect Guidance for Industry and Food and Drug Administration Staff. The guidance formally outlines when the FDA intends to enforce UDI labeling, GUDID data submissions, standard date format, and direct marking requirements for Class I and unclassified devices that are not implantable, life-supporting, or life-sustaining. 


The guidance reflects both the extension provided in the Letter to Device Labelers on UDI Compliance Dates for Class I and Unclassified Devices – June 2, 2017 as well as the three-year grace period for products manufactured and labeled prior to the compliance date published in the final rule. See the below table for details on when the FDA intends to enforce the requirements:


Type of Device &
Manufacture and Labeling Date

UDI Labeling
(21 CFR 801.20 & 801.50)
GUDID Data Submission
(21 CFR 830.300)
Standard Date Format
(21 CFR 801.18)

Direct Marking
(21 CFR 801.45)

Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018 September 24, 2020September 24, 2022
Finished class 1 and unclassified devices manufactured and labeled before September 24, 2018September 24, 2021September 24, 2022


Reminder: Class I devices that are exempt from GMP requirements are excepted from the UDI labeling requirements. 


Click to view the guidance:

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm592340.pdf

    

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