FDA delays enforcement dates for class I and unclassified device UDIs by two years

The Food and Drug Administration (FDA) has released new guidance which pushes back the date by which the FDA will enforce certain unique device identifier (UDI) requirements for class I and unclassified devices by two years.

The new dates when the FDA will enforce certain UDI requirements for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are as follows:

  • 24th September 2020 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
  • 24th December 2022 for direct market requirements (21 CFR 801.45).

The guidance states that finished class I and unclassified devices, other than I/LS/LS devices, manufactured and labelled prior to 24th September 2018 are excluded from UDI labelling and GUDID data submission requirements for a period of three years after the established compliance date or until 24th September 2021.

The FDA “intends to focus its resources on addressing existing implementation challenges and optimising the quality and utility of UDI data for higher-risk devices before focusing on UDI implementation issues for lower-risk devices”. The FDA believes that this will help to ensure the transition from development of the unique device identification system to widespread use and sustainability.

The guidance also states the FDA’s direct mark compliance policy for class III, LS/LS, and class II devices that are non-sterile, are manufactured and labelled prior to their applicable direct mark compliance date and that remain in inventory, as well as for class I and unclassified devices that are non-sterile, that are manufactured and labelled prior to 24th September 2022 and that remain in inventory.

It is important to note that the FDA “does not intend to enforce the direct mark requirements under 21 CFR 801.45 for these devices when the device’s unique device identifier (UDI) can be derived from other information directly marked on the device”.

To read more about the UDI policy regarding compliance dates for class I and unclassified devices and certain devices requiring direct marketing, please click here.