Details on Medical Device Labeling Requirements

Medical device labeling is more than just the label on the product. According to the U.S. Food and Drug Administration, medical device labeling includes all of the details provided with a product, such as:

Medical Device Labeling Requirements and Standards

Jurisdictions around the world have strict medical device labeling requirements. Some of the most frequently referenced standards include:

The level of requirements depends on the type of medical device, so it pays to be well-versed in the regulations of the areas where you distribute your devices.

It's critical to stay abreast of labeling regulatory requirements for medical devices, as they are subject to change. For instance, U.S. federal regulations now allow the medical device industry to use medical device labeling symbols without a written explanation as long as a print or electronic glossary of the symbols is available.

Part of the Food and Drug Administration's medical device labeling requirements focuses on the Unique Device Identifier, a numeric or alphanumeric code that helps to:

• Identify medical devices
• Protect against counterfeits
• Allow devices to be recalled quickly
• Provide more accurate reporting

FDA regulations mandate that the UDI label code include:

• A device identifier specific to a model, such as a part number
• A production identifier — any number given to a specific device during production, such as a lot or batch number within which a device was manufactured, a serial number, an expiration date or a manufacturing date

U.S. federal regulations require that the UDI label contain a scannable code, like a barcode, as well as human-readable text.