Although there are different ISO standards which define the requirements for labelling related to medical device, such us ISO 15223-1 and ISO 20417, FDA has also some specific requirements that we are going to summarise in this post.
This article will talk about the general FDA regulation for labelling of medical device, including labelling for Investigational Device.
4EasyReg published an e-book containing a comprehensive overview of the labelling requirements for EU and FDA, which takes in consideration new or updated ISO standards related to labelling and IFU.
First of all some definitions, as usual. The FDA definition of label is: “display of written, printed, or graphic matter upon the immediate container of any article…”. Instead the labelling is defined as “all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article’ at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce”.
It is essential to mention that according to FDA, all the advertising materials are considered labelling and they fall under the FDA regulations.
Medical Device Labelling: Overview of FDA regulations
The FDA requirements for labelling of medical devices are embedded with Quality System Regulation requirements mentioned in 21 CFR Part 820. This includes activities for labelling control, incoming control of materials (including labelling) and design documentation to ensure labels have adequate space on the device and packaging.
For active medical devices, the requirements related to durability and legibility of the label are enclosed within IEC 60601-1 as well.
From design process point of view, labelling specifications shall be included in the Design History File of the device. One method to deal with this is to prepare a “Labelling Specification” document, with a list of all the requirements related to the labelling. These requirements are then checked in he framework of validation activities to ensure that no deviations are identified.
Changes in labelling shall be handled through a change control process, where the impact of the change shall be evaluated. The evaluation shall take in consideration the regulatory impact of the change and, potentially, the necessity of regulatory submission fo clearance of the modified device.
Finally, one note regarding over labelling and re-labelling activities which are discouraged by the agency but accepted as far as the new labelling meets all the applicable regulatory requirements.
Labelling for Sterile Devices for the FDA
Requirements for sterile medical devices are well described in the ISO 15223-1. However particular attention shall be given to the following situations:
- warning shall be included in case only a part of the device is sterile
- attention shall be given when re-sterilization is not recommended
- adequate information shall be given for devices which are intended to be sterilised before use by the user.
Labelling for Over The Counter Devices
FDA labelling requirements for Over The Counter Devices is slightly different from prescription devices. In particular, there three main topics which need attention:
- Requirements of the Principal Display Panel
- Statement of Identify
- Declaration of net quantity of contents.
For the Principal Display Panel (it is the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale), there are different requirements related to position and the size of this part. These requirements are dependent from the shape of the package.
A statement of identity shall be included in the principal display panel. The statement shall include the name of the device and “an accurate statement of the principal intended action(s) of the device”.
Finally, the Principal Display Panel shall include as well a declaration of net quantity of contents.
Unique Device Identification
FDA-related UDI requirements are quite complex and will be explained in details in a different post coming soon. Currently, all the devices sold in United States must bring a UDI in the device label and on the package. Furthermore, all the devices subject of UDI requirements need to be registered in a specific public database called GUDID.
Labelling Requirements for Investigational Devices
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study. These devices have specific requirements in terms of labelling, which are explained in 21 CFR 812 . In particular, the main requirement is related to the following statement “CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use” that shall be included in the labelling.
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