mdi ConsultantsFDA Update – June 30, 2020
FDA Issues Guidance Regarding Compliance Dates for Unique Device Identification Requirements
On June 30, 2020, the FDA issued the guidance Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking for immediate effect. The unique device identification (UDI) system is designed to adequately identify devices through distribution and use. The requirements were designed to be rolled in over seven years. This was according to established compliance states that were based primarily on device classification. This guidance describes the FDA’s intention with regard to enforcement of requirements for class I and unclassified devices. Additionally, this guidance describes the 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.
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).
The FDA published the UDI rule on September 24, 2013. Phased implementation of the requirements set forth in that final rule is based on a series of established compliance dates based primarily on device classification that ranges from September 24, 2014, to September 24, 2020. The rule requires a device to bear a UDI on its label and packages unless an exception or alternative applies (21 CFR 801.20), and special labeling requirements apply to stand-alone software regulated as a device. The UDI rule also requires that data pertaining to key characteristics of each device required to bear a UDI be submitted to FDA’s GUDID. Additionally, the UDI rule added standard date formatting which requires certain dates on device labels to be in standard format. The FDA aligned the compliance date for standard date format requirements with the compliance date by which a device must bear a UDI on its label and packages to avoid the need for changes to a device label to occur more than once in order to implement the requirements. Currently, the FDA does not intend to enforce standard date formatting, UDI labeling, and GUDID data submission requirements for class I and unclassified devices, other than I/LS/LS devices, before September 24, 2022.
The policy for class III and class II devices in Section IV.A. of this guidance applies to finished class III, LS/LS, and class II devices that are non-sterile, that were manufactured and labeled prior to their established direct mark compliance date, and that remain in inventory. The direct mark compliance date for class III devices is September 24, 2016; for LS/LS devices is September 24, 2015; and for class II devices is September 24, 2018. Finished devices that are manufactured and labeled prior to applicable compliance date established by FDA 21 CFR 801.20 are not required to comply with UDI requirements, including direct mark requirements, until three years after that labeling compliance date.
The policy for direct mark compliance date in Section IV.B. for class I and unclassified devices, except for LS/LS devices, is September 24, 2020. The FDA currently does not intend to enforce UDI direct mark requirements under 21 CFR 801.45 for those devices before September 24, 2022. This policy applies to sterile and non-sterile devices and includes device constituents of a co-packaged combination product or kit.
mdi has been assisting our clients on understand these regulations and complying with them.
For further assistance and questions on this guidance document, please email mdi Consultants at [email protected] RE: UDI.