Medical device companies who wish to sell their products in the United States must adhere to the regulations supplied by the FDA for labeling medical devices.
Medical devices, food products, and pharmaceuticals all share something in common: labeling regulations that are established by the FDA to help protect customers. Product labels are crucial for devices that will come into contact with or enter the human body. Product labels on medical devices help to educate patients about how a device should be used, who should use the device, what risks the device could pose to the end user (patient or care provider), and how to operate the device safely.
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 FDA Provides Extensive Guidelines For Labeling
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.
FDA QSR Requirements For Labeling Medical Devices
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:
- Label Integrity - Medical device companies must print and apply labels that will remain legible and affixed to their products throughout the normal process of storage, handling, distribution and appropriate use of the product. There is no purpose in having a compliant label that falls off easily during storage or shipping.
- Labeling Inspection - The label for the device must be examined for accuracy before it can be used to label the product. The examination should ensure that the label has the correct unique device identifier (UDI) code, expiration date, control number, storage and handling instructions, indications of use, and any additional important information. Documentation of this review process, including the date and approval signature, should be documented in the device history record (DHR).
- Labeling Storage - Medical device manufacturers must design their labeling storage system in a way that properly identifies labels and prevents mix-ups between labels. Adequate labeling storage controls prevent labels from being erroneously misapplied to the incorrect product.
- Labeling Operations - Manufacturers must control the labeling process to prevent mix-ups and ensure labels are applied to the correct device. The device history record should be updated with the label and labeling used for each production unit, lot or batch of product.
- Control Number - Medical devices that meet the traceability requirements of 21 CFR Part 820.65 must be accompanied by a control number from manufacturing through distribution.
Medical Device Companies Use Greenlight Guru To Manage Labels and DHR
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.