Medical Device Labeling & Product Review

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:

1. 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.
2. 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).
3. 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.
4. 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.
5. 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.

To have “FDA Registration Assistance” review your Medical Device Products and Labels please CONTACT US.