Global Market Intelligence Service (GMIS) News Article:
USFDA Publishes Guidance of Enforcement Discretion for UDI (Unique Device Identification) Compliance Dates – Class I and Unclassified Devices
On January 16, 2018, the FDA released a guidance document, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices. This guidance, with initial intent released in June 2017, describes FDA’s intention with regard to enforcement of these requirements for class I and unclassified devices. The FDA does not intend to enforce standard date formatting, labeling, and GUDID data submission requirements under 21 CFR 801.18 (standard date formatting), 21 CFR 801.20 (labeling), 21 CFR 801.50 (labeling), and 21 CFR 830.300 (GUDID data submission) for these devices before September 24, 2020; In addition, FDA does not intend to enforce direct mark requirements under 21 CFR 801.45 for these devices before September 24, 2022. The policy described in this guidance does not apply to I/LS/LS (implantable, life-supporting or life-sustaining) devices. This policy also does not apply to class I devices that FDA has by regulation exempted from the good manufacturing practice requirements because such devices are excepted from UDI requirements (see 21 CFR 801.30(a)(2)).
In addition, 21 CFR 801.30(a)(1) provides that a finished device manufactured and labeled prior to the compliance date established by the FDA for 21 CFR 801.20 regarding that device is excepted from the requirement to bear a UDI for a period of three years after that compliance date. Finished class 1 and unclassified devices manufactured and labeled before September 24, 2018 will need to comply with the FDA requirement by September 24, 2021. In correlation, the FDA does not intend to enforce direct mark requirements before September 24, 2022.
The UDI Rule, established in 2013, requires devices to bear a unique device identifier (UDI) on its label and packages unless an exception or alternative applies (see 21 CFR 801.20), and special labeling requirements apply to stand-alone software regulated as a device (21 CFR 801.50). The unique device identification system requirements are being phased in over seven years according to established compliance dates based primarily on device classification. For class II, class III, and I/LS/LS devices, the compliance dates established for most UDI requirements have already passed. The FDA received a large number of inquiries from labelers of class II, class III, and I/LS/LS devices relating to those policy and technical issues and as a result to these inquiries, the FDA is anticipating a similar outcome for class I devices and are taking an approach to minimize the inquiry volume that is expected.
|Type of Device||FDA does not intend to enforce UDI labeling, GUDID Data Submission and Standard Date Format requirements before:||FDA does not intend to enforce Direct Mark requirements before:|
|Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018||September 24, 2020||September 24, 2022||Finished class 1 and unclassified devices manufactured and labeled before September 24, 2018||September 24, 2021||September 24, 2022|
- Initial Letter of Intent – UDI compliance date for class I and unclassified devices
- Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Device
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