In the world of medical devices, proper labeling isn’t just a regulatory requirement, it is a vital component of patient safety, product usability, and market access.

Whether you’re a manufacturer navigating FDA regulations, a distributor handling multilingual packaging for international markets, or a startup preparing your first 510(k) submission, understanding labeling requirements is critical.  

FDA defines labeling broadly under 21 CFR Part 801 as all labels and “other written, printed, or graphic matter” accompanying the device. This encompasses everything from product and outer packaging, promotional materials, instructions for use (IFU) and packaging to symbols, digital labels, and more. 

Labeling is more than just a formality—it’s a cornerstone of safe and effective medical device use. Incomplete or inaccurate labeling can lead to misuse, device failure, adverse events, and even patient harm. Regulators like the FDA and international bodies such as the European Commission consider labeling an essential component of a device’s safety and performance profile. 

Clear, comprehensive labeling ensures that users—whether patients, caregivers, or healthcare professionals—can understand how to properly operate the device, recognize its indications and contraindications, follow safety precautions, and interpret warnings or limitations.

It also supports traceability, facilitates proper storage and handling, and is often critical during recalls or adverse event investigations. 

For most medical devices, labels must include the following (per 21 CFR 801 and, if applicable, 21 CFR 809 for IVDs): 

Name and Address

• Manufacturer’s name and business location
• If imported, also include U.S. agent/distributor

Intended Use / Indications for Use

• Must match the 510(k), PMA, or De Novo clearance/approval
• Can’t suggest off-label use

Device Name and Model/Reference Number

• Specific model/catalog number clearly stated

Lot or Serial Number

• Must allow for traceability

UDI (Unique Device Identifier)

• Required for most Class II and III devices
• Includes machine-readable (barcode) and human-readable formats

Expiration Date and/or Manufacturing Date 

• Required for sterile or time-sensitive devices

Instructions for Use (IFU) 

• Required when necessary for safe and effective use

Warnings and Precautions 

• Especially for implantable, life-supporting, or high-risk devices

Sterilization and Storage Conditions 

• Indicate sterilization method, single-use or reusable, shelf life, etc.

Rx or OTC Designation 

• Devices intended only for professionals must be labeled with:

“Caution: Federal law restricts this device to sale by or on the order of a [licensed healthcare practitioner].”