UDI Labeling for Clinical Investigational Device

#1
Dear all,

I would like to get the view of the Cove community on the following UDI question. There is a 510k cleared device placed on the US market. The device has a slightly different Intended Use as the CE marked EU version does. If the EU version is being adopted again for the purpose of an clinical investigation Phase I in the US does this need to be UDI labeled? The 510k will be referenced in the IND submission with FDA. Please let me know your thoughts about this.

Regards.
 
Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
Hi, per FDA "UDI System: Small Entity Compliance Guide", investigational devices (21CFR812.3; meaning a device, including a transitional device, which is the object of an investigation.) is exempt from UDI labelling requirements.
 
#3
Hi, I am seeking further clarification on UDI Labeling for a Clinical Investigational Device. Whilst these devices are exempt from UDI labeling requirements there appears to be a change in labeling requirements.

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.
source: FDA - Device Regulation and Guidance - Unique Device Identification document

This comes into affect 24 Sept 2018.

I am wondering if an investigational device that currently does not give month or day but only year must change it's label and if so to what?
 
#4
The dates have been pushed by FDA for UDI compliance. FDA published a guidance on 16-Jan-2018 regarding the new compliance date.

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.

Coming to second part of your question, if you still want to comply to the regulation then you fall under the voluntary compliance for UDI.

Sec. 801.35 Voluntary labeling of a device with a unique device identifier.

(a) The labeler of a device that is not required to bear a unique device identifier (UDI) may voluntarily comply with 801.20. If a labeler voluntarily includes a UDI for a device, the labeler may voluntarily provide information concerning the device under subpart E of part 830 of this chapter.

(b) A device may bear both a Universal Product Code (UPC) and a UDI on its label and packages.
 
Thread starter Similar threads Forum Replies Date
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
K UDI Labeling for Medical Device Samples 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T UDI Labeling of Convenience Kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q UDI- RFID Labeling Other US Medical Device Regulations 4
C Labeling and UDI requirements for medical device kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Pmarszal UDI (Unique Device Identification) Transition Period - Packaging Labeling Other US Medical Device Regulations 5
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
M GUDID/UDI Packaging and Labeling Questions Other US Medical Device Regulations 6
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 3
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
M Basic UDI and technical documentation EU Medical Device Regulations 1
M MDR Requirements - UDI/Barcodes/QR codes on IFUs EU Medical Device Regulations 4
M UDI transition period and implementation EU Medical Device Regulations 6
M UDI size on packaging EU Medical Device Regulations 3
R UDI for US - Third Party device Repackager Other US Medical Device Regulations 9
M UDI placement - Packaging levels EU Medical Device Regulations 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M DI format for UDI after we have registered it with GS1 Other US Medical Device Regulations 0
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 5
M UDI-PI on a package that contains more devices EU Medical Device Regulations 3
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 6
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
P UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications? EU Medical Device Regulations 8
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
K Hospital UDI requirements Other Medical Device and Orthopedic Related Topics 7
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
J UDI Requirements - Products that all fall under the same family 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0
M Informational EU – EUDAMED UDI Device Data Dictionary + data sets Medical Device and FDA Regulations and Standards News 0
M EU MDR - UDI requirements and responsibility guidance EU Medical Device Regulations 1
A UDI requirements for pre-filled combination devices - Box containing a pre-filled device US Food and Drug Administration (FDA) 2
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22

Similar threads

Top Bottom