Source: https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/compliance-dates-udi-requirements
Timestamp: 2019-11-18 02:37:49
Document Index: 236242719

Matched Legal Cases: ['§ 801', '§ 801', '§ 801', '§ 801', '§ 801', '§ 801', '§ 801', '§ 801']

Compliance Dates for UDI Requirements | FDA
Determine if your product meets the definition of a device.
How to determine device class
FDA established key compliance dates in conjunction with the Unique Device Identification System final rule.
Compliance dates for all other provisions of the final rule. Except for the provisions listed below, FDA requires full compliance with the final rule as of the effective date that applies to the provision.
Requirements by device type:
Devices Excepted From or Not Subject to UDI Labeling Requirements
Class I and unclassified medical devices (including enforcement discretion for these devices)
Class III and devices licensed under the Public Health Service Act (PHS)
Requirements by Device Type
September 24, 2018 Dates on the labels of devices, excepted from or not subject to the UDI labeling requirements, must be formatted as required by § 801.18.
Class I and Unclassified Medical Devices
September 24, 2020 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.
September 24, 2018 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.
FDA issued a guidance establishing enforcement discretion that applies to the compliance dates for Class I and unclassified devices:
Class I and unclassified devices manufactured and labeled on or after September 24, 2018 FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before: September 24, 2020
FDA does not intend to enforce Direct Mark requirements (21 CFR 801.45) before: September 24, 2022
Finished Class I and unclassified devices manufactured and labeled before September 24, 2018 FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before: September 24, 2021
These enforcement discretion dates do not apply to Class I or unclassified implantable, life-supporting or life-sustaining devices; labelers of these devices must already be in compliance with UDI requirements. Class I CGMP-exempt devices are excepted from UDI requirements. 21 CFR 801.30(a)(2).
Consistent with 21 CFR 801.30(a)(1), finished class I and unclassified devices manufactured and labeled before September 24, 2018, are excepted from the UDI labeling and GUDID submission requirements by regulation until September 24, 2021.
Guidance: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
Letter: Letter to Device Labelers on UDI Compliance Dates for Class I and Unclassified Devices – June 2, 2017 (PDF 80KB)
September 24, 2018 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.
September 24, 2016 The labels and packages of class II medical devices must bear a UDI. § 801.20.
Class III Medical Devices and Devices Licensed under the Public Health Service Act (PHS)
September 24, 2016 A class III 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.
September 24, 2014 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.
Implantable, Life-Saving, and Life-Sustaining Medical Devices
September 24, 2015 The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20.
How to Determine if a Device Is Implantable, Life-Saving, and Life-Sustaining
The FDA recommends that device labelers:
Check the list of medical devices the FDA classifies as implantable, life-saving, and life-sustaining for purposes of section 614 of FDASIA amending section 519(f) of the FDC Act, March 2015 (PDF - 84KB). Labelers may refer to this link as a guide, but it is not a definitive list of implantable, life-saving, and life-sustaining devices subject to the September 24, 2015 UDI compliance date.
Search the CDRH Product Classification database for the most current information on FDA product codes to determine if the devices within an FDA product code are considered implantable, life-saving (life-sustaining), or life-supporting.
Evaluate the characteristics of the device and look to the device’s intended use to determine whether a particular device is life-saving, life-sustaining or implantable and follow the appropriate compliance dates and rules. For the purposes of determining the applicability of UDI requirements, refer to 21 CFR 860.3(e) for the definition of life-supporting or life-sustaining device, and refer to 21 CFR 801.3 for the definition of implantable device.