Constructing a device’s Unique Device Identifier (UDI) Background The US FDA’s UDI Final Rule (21 CFR 801.45), requires “[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.” Permanent marking is also referred to as “Direct Marking.” The compliance date for Class II devices was September 24, 2016 for devices to be labeled with its UDI. The compliant date for direct marking newly manufactured and labeled Class II devices was originally September 24, 2018. However, Class II devices remaining in Integra’s inventory manufactured and labeled prior to the September 2016, the compliance date is September 24, 2019. This means any device remaining in inventory as of September 25, 2019 would need to be reworked to have both a UDI compliant label and direct mark (if required). FDA Publishes Enforcement Discretion for Direct Marking Requirements FDA has since published an enforcement discretion guidance allowing device labelers to provide a process for users to “derive” a device’s UDI at the point of use. Certain information must already be “marked” on a device in order for a UDI to be derived. These are a device’s part/catalog number, or lot number or both part/catalog and lot numbers. FDA also allowed for use of a device’s serial number to be used, but Integra does not use serial numbers on the devices subject to this enforcement discretion. Integra also uses a device’s part/catalog number as its version/model number. Devices whose UDI can be derived, will not need to be direct marked per the published Enforcement Discretion. Integra has submitted product information to FDA’s Global Unique Device Identification Database (GUDID – https://accessgudid.nlm.nih.gov/) about its devices including each device’s part/catalog number. You will need access to a computer with Internet capabilities to be able to use the methods outlined here for constructing a device’s UDI. What do I do if I cannot find my device in GUDID? Device Class Manufactured & Labeled Prior to: Direct Mark Compliance Date (new inventory) Direct Mark Compliance Date (existing inventory) Class II (non-sterile devices only) September 24, 2018 September 24, 2018 September 24, 2019 (unless UDI can be derived) Class I & Unclassified September 24, 2022 September 24, 2022 September 24, 2022 (unless UDI can be derived)
Transcript
Constructing a device’s Unique Device Identifier (UDI)
Background
The US FDA’s UDI Final Rule (21 CFR 801.45), requires “[a] device that must bear a unique
device identifier (UDI) on its label must also bear a permanent marking providing the UDI on
the device itself if the device is intended to be used more than once and intended to be
reprocessed before each use.” Permanent marking is also referred to as “Direct Marking.” The
compliance date for Class II devices was September 24, 2016 for devices to be labeled with its
UDI. The compliant date for direct marking newly manufactured and labeled Class II devices
was originally September 24, 2018. However, Class II devices remaining in Integra’s inventory
manufactured and labeled prior to the September 2016, the compliance date is September 24,
2019. This means any device remaining in inventory as of September 25, 2019 would need to be
reworked to have both a UDI compliant label and direct mark (if required).
FDA Publishes Enforcement Discretion for Direct Marking Requirements
FDA has since published an enforcement discretion guidance allowing device labelers to provide
a process for users to “derive” a device’s UDI at the point of use. Certain information must
already be “marked” on a device in order for a UDI to be derived. These are a device’s
part/catalog number, or lot number or both part/catalog and lot numbers. FDA also allowed for
use of a device’s serial number to be used, but Integra does not use serial numbers on the
devices subject to this enforcement discretion. Integra also uses a device’s part/catalog number
as its version/model number. Devices whose UDI can be derived, will not need to be direct
marked per the published Enforcement Discretion.
Integra has submitted product information to FDA’s Global Unique Device Identification
Database (GUDID – https://accessgudid.nlm.nih.gov/) about its devices including each device’s
part/catalog number. You will need access to a computer with Internet capabilities to be able to
use the methods outlined here for constructing a device’s UDI.
What do I do if I cannot find my device in GUDID?
Device Class Manufactured & Labeled Prior to:
Direct Mark Compliance Date (new inventory)
Direct Mark Compliance Date (existing inventory)
Class II (non-sterile devices only)
September 24, 2018 September 24, 2018 September 24, 2019 (unless UDI can be derived)
Class I & Unclassified September 24, 2022 September 24, 2022 September 24, 2022 (unless UDI can be derived)
