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ISO 13485:2016, the leading international standard for medical device quality systems, describes a label as the instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents. Labels ensure that when a customer purchases a medical device, they have immediate access to the best information pertaining to the safe operation of the device.
The specific requirements for labeling your medical device will depend on what type of device your company manufactures. In 21 CFR Part 801, the FDA publishes detailed regulations that govern the labeling of medical devices for sale in the United States. In addition to the general labeling provisions that apply to all devices, there are special sub-parts that apply to devices with unique device identification and over-the-counter devices, as well as detailed exemptions and special requirements for specific types of devices.
Medical device companies should determine the risk classification and intended use for their devices before developing detailed labeling requirements. All medical device labels are to include the name and address of the manufacturer, packer or distributor, along with adequate directions for use.
If your medical device company is planning to sell devices in the United States, you will need to comply with the FDA QSR for Labeling and Packaging Control of medical devices, found in 21 CFR Part 820.120. The focus of these controls is to ensure that labels are accurately designed and properly applied to the correct products.
The section requires that medical device companies establish and maintain a procedure to control labeling activities. It also mandates five different types of controls for device labeling:
Greenlight Guru offers a medical device specific eQMS software platform that provides companies with the convenience and ease of managing their device labels from directly within the software. Our solution provides users with the functionality to upload, route, and approve their labels, just as they would any other document.
Greenlight Guru allows medical device companies to generate a device history record that includes the results of the labeling inspection, updated labeling information for new lots or batches of product and the required SOPs for medical device labeling. This feature makes it easier than ever for medical device manufacturers to demonstrate compliance with the FDA's requirements for labeling medical devices.
FREE DOWNLOAD: Click here to download your PDF copy of our FDA Labeling Requirements Checklist.
Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's medical device QMS software →