UDI Labeling for Clinical Investigational Device

K

kenyon85

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.
 
chris1price

chris1price

Trusted Information Resource
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.
 
Lancaster

Lancaster

Registered
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?
 
S

Sulamistan

Moved On
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.
 
A

anazuzo

Registered
A follow up to this question - Is there an UDI exemption for clinical investigation performed in EU under 2017/745 Medical Device Regulation?

Thank you,
anazuzo
 
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