Compliance Dates for UDI Requirements

The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
Class III stand-alone software must provide its UDI as required by § 801.50(b).
  • The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20.
    Dates on the labels of these devices must be formatted as required by § 801.18.
  • A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. § 801.45.
    Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b).
  • Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
  • Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
  • The labels and packages of class II medical devices must bear a UDI. § 801.20.
    Dates on the labels of these devices must be formatted as required by § 801.18.
    Class II stand-alone software must provide its UDI as required by § 801.50(b).
  • Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
  • A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
  • The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20.
    Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18.
  • Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300.
    Class I stand-alone software must provide its UDI as required by § 801.50(b).
Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
FDA mandates regarding the GUDID registry and UDI Compliance have been in place for a long while with specific action dates planned for the multi-year roll out of the new rules to allow various classes of companies to reach full compliance over a staggered period of regulatory transition. UDI Compliance Solutions is your strategic partner at the forefront of these important new parameters and we are available to assist you at each step with the new and upcoming criteria relevant to your specific operations. Contact us now to determine which dates apply to you and to learn more about the man ways our expert staff can assist you with becoming fully compliant in the fastest, most efficient and cost-effective manner thanks to our proprietary software and world class team of UDI Compliance professionals.
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UDI Dataflow
This FDA schematic flowchart is intended to give you a printable roadmap to compliance with the FDA’s latest UDI labeling requirements.  And while colorful and complete, not all small and medium-sized medical device manufacturers utilize the the ERP and database technologies depicted in this flowchart.  Our goal at UDI Compliance Solutions is to SIMPLIFY IT!! We are available to assist you at each step along the way and we have extensive experience with all facets of UDI labeling, so please put our expertise to use as part of your compliance planning and allow us to demonstrate the fastest, best and most affordable methods of making sure you are always operating within the framework established by the FDA’s UDI labeling mandates.