Compliance Dates for UDI Regulatory Requirements

Posted By on Jul 8, 2015 | 4 comments


Key compliance dates in the UDI final rule.

Compliance Date Requirement
September 24, 2014 All Class III devicesThe 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).

September 24, 2015 Class II Implantable, life-saving, and life-preserving DevicesThe 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.
September 24, 2016 Remaining Class II DevicesThese are 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.
September 24, 2018 All Remaining DevicesDevice 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).
Compliance dates for all other provisions of the final rule.  Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.

These compliance dates will impact 510k and PMA submissions.  Contact us and our FDA Regulatory Consultant will help you guide your firm through the new paradigm.

 

4 Comments

    • Thank you- Note UDI labels will be required for all FDA Registrations

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