The USA: FDA is holding back the enforcement of certain UDI requirements
The US Food and Drug Administration (FDA) has published final guidance for unique device identification compliance dates for Class I and Unclassified Medical Devices. This immediately in effect guidance also clarifies the Agency policy concerning compliance dates for certain Devices requiring direct marking.
The compliance dates established for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are:
- September 24, 2018, for the following requirements:
- Standard date formatting (21 CFR 801.18),
- Labeling (21 CFR 801.20, 21 CFR 801.50), and
- Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300); and
- September 24, 2020, for direct mark requirements (21 CFR 801.45).
“This guidance also describes FDA’s direct mark compliance policy for class III, LS/LS, and class II devices that are non-sterile, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for class I and unclassified devices that are not LS/LS devices, that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory.”
FDA recognized that “preparing to implement UDI requirements while addressing the challenges related to Coronavirus Disease 2019 (COVID-19) could be very difficult and could divert resources from COVID-19 response efforts.” Therefore, it indicates “To the extent this policy helps labelers remain focused on public health needs related to COVID-19, we believe the policy is further consistent with the public health.”
For more information, please see the guidance document from the FDA.
Contact Meditrial for immediate assistance in the US or in Europe.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
