![code on time alternative code on time alternative](https://pbs.twimg.com/media/E5PEgpLXwAc0DJd.jpg)
If the FDA grants an exception or alternative, we may include any safeguards or conditions deemed appropriate to ensure the adequate identification of the device through its distribution and use. In response to labeler requests or on our own initiative, the FDA may grant an exception or alternative if an exception is appropriate because the requirements of 21 CFR 801 Subpart B are not technologically feasible, or that an alternative would provide for more accurate, precise, or rapid device identification than the requirements of 21 CFR 801 Subpart B or would better ensure the safety or effectiveness of the device that would be subject to the alternative. Request for an exception from or alternative to a UDI requirement ( § 801.55)Ī labeler may submit a request for an exception from or alternative to the requirement for the label of a device to bear a unique device identifier ( § 801.20) or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device. A labeler of a device identified in § 801.30 is not required to request an exception from the FDA. A device within one or more of these exceptions is not required to bear a UDI. Under § 801.30, the UDI rule provides general exceptions from UDI labeling requirements to certain categories of devices. Unique Device Identification: Direct Marking of Devices: Guidance for Industry and Food and Drug Administration Staffġ Implantable devices are not subject to direct mark requirements.Įxceptions and Alternatives General exceptions from the requirement for the label of a device to bear a unique device identifier ( § 801.30) Immediately in Effect Guidance for Industry and Food and Drug Administration StaffĬlass II devices other than implantable 1, life-sustaining, and life-supporting (I/LS/LS) devicesĬonsigned and loaned devices of all classesĬonsigned and loaned prior to applicable label compliance date Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking. Resources for policies that apply to certain devices subject to UDI Direct MarkingĪdditional information pertaining to direct mark requirements For more information on the policies that apply to certain devices subject to UDI direct marking, see Figure 2, below. The FDA does not intend to enforce the direct mark requirements under 21 CFR 801.45 for finished class III, LS/LS, and class II non-sterile devices, requiring a direct mark, that are manufactured and labeled prior to their applicable direct mark compliance date, and that remain in inventory, as well as for finished class I and unclassified devices that are non-sterile, that are manufactured and labeled prior to September 24, 2022, and that remain in inventory, provided the device bears a non-UDI direct mark and the labeler has developed a method by which, using the non-UDI mark, the UDI may be made available. This guidance also describes the FDA's direct mark compliance policy.