What Is Medical Device Labeling?

According to the FDA, medical device labels need to meet labeling requirements. When a medical device has not complied with these requirements, the FDA takes action according to the primary law of the Federal Food, Drug, and Cosmetic Act (FFD & C Act).

Section 201(k) defines ‘label’ as a:

• Display of written, printed, or graphic matter upon the immediate container of any article

The term ‘immediate container’ does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear ‘on the outside container or wrapper, if any there be, or the retail package of such article, or is easily legible through the outside container of wrapper.’

Section 201(m) defines ‘labeling’ as:

• All labels and other written, printed, or graphic matter
• Upon any article or any of its containers or wrappers, or
• Accompanying such article’ at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

US FDA Medical Device Labeling Regulations

Title 21 of the Code of Federal Regulations provides detailed guidelines for medical device labeling. Specifically, 21 CFR Part 801 comprehensively addresses all aspects of labeling, ranging from Unique Device Identification (UDI) requirements to translation considerations. 21 CFR Part 820 – Quality System Regulation, Section 820.120 outlines labeling controls and monitoring procedures as part of your quality management system (QMS).

FDA Quality System Regulation Requirements for Labeling Medical Devices

Each manufacturer shall establish and maintain procedures to control labeling activities.

(a) Label integrity: Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate use.

(b) Labeling inspection: Labeling shall not be released for storage or use until a designated individual(s) has examined the labeling for accuracy including, where applicable, the correct unique device identifier (UDI) or universal product code (UPC), expiration date, control number, storage instructions, handling instructions, and any additional processing instructions. The release, including the date and signature of the individual(s) performing the examination, shall be documented in the DHR.

(c) Labeling storage. Each manufacturer shall store labeling in a manner that provides proper identification and is designed to prevent mixups.

 (d) Labeling operations. Each manufacturer shall control labeling and packaging operations to prevent labeling mix-ups. The label and labeling used for each production unit, lot, or batch shall be documented in the DHR.

(e) Control number. Where a control number is required by section 820.65, that control number shall be on or shall accompany the device through distribution.

General Medical Device Labeling Requirements

The following components should be required for an FDA-compliant label:

• Name and place of business of manufacturer, packer or distributor.
• Intended use
• Adequate directions for use
• Misleading statements
• Prominence of required label statements; use of symbols in labeling.
• Spanish-language version of certain required statements.

If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language, such labeling is authorized under 801.15(c).

• Format of dates provided on a medical device label.

Unique Device Identification

Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution. A unique device identifier is composed of:

(1) A device identifier – a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and

(2) A production identifier – a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:

• The lot or batch within which a device was manufactured;
• The serial number of a specific device;
• The expiration date of a specific device;
• The date a specific device was manufactured;

Labeling Requirements for Unique Device Identification

1. Label to bear a unique device identifier

The label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of the subpart B of 21 CFR 801 and 21 CFR part 830 of this chapter.

2. General exceptions from the requirement for the label of a device to bear a unique device identifier

The following types of devices are excepted from the requirement of section 801.20; a device within one or more of the following exceptions is not required to bear a unique device identifier (UDI):

• A finished device manufactured and labeled prior to the compliance date established by FDA for section 801.20 regarding the device. This exception expires with regard to a particular device 3 years after the compliance date established by FDA for the device.
• A class I device that FDA has by regulation exempted from the good manufacturing practice requirements of part 820 of this chapter, exclusive of any continuing requirement for recordkeeping under section 820.180 and 820.198.

3. Voluntary labeling of a device with a unique device identifier

The labeler of a device that is not required to bear a unique device identifier (UDI) may voluntarily comply with section 801.20. If a labeler voluntarily includes a UDI for a device, the labeler may voluntarily provide information concerning the device under subpart E of part 830 of this chapter.

4. Form of a unique device identifier

Every unique device identifier (UDI) must meet the technical requirements of section 830.20 of this chapter. The UDI must be presented in two forms:

• Easily readable plain-text, and
• Automatic identification and data capture (AIDC) technology.

5. Devices that must be directly marked with a unique device identifier

A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.

The UDI provided through a direct marking on a device may be:

• Identical to the UDI that appears on the label of the device, or
• A different UDI used to distinguish the unpackaged device from any device package containing the device.

6. Labeling requirements for stand-alone software

Stand-alone software regulated as a medical device must provide its unique device identifier through either or both of the following:

• An easily readable plain-text statement displayed whenever the software is started;
• An easily readable plain-text statement displayed through a menu command (e.g., an “About * * *” command).

Stand-alone software that is distributed in both packaged form and in a form that is not packaged (e.g., when downloaded from a Web site) may be identified with the same device identifier. 

7. Request for an exception from or alternative to a unique device identifier requirement

A labeler may submit a request for an exception from or alternative to the requirement of section 801.20 or any other requirement of this subpart for a specified device or a specified type of device. A written request for an exception or alternative must:

• If requesting an exception, explain why you believe the requirements of this subpart are not technologically feasible;
• If requesting an alternative, describe the alternative and explain why it would provide for more accurate, precise, or rapid device identification than the requirements of this subpart or how the alternative would better ensure the safety or effectiveness of the device that would be subject to the alternative;

8. Discontinuation of legacy FDA identification numbers assigned to devices

On the date your device must bear a unique device identifier (UDI) on its label, any National Health-Related Item Code (NHRIC) or National Drug Code (NDC) number assigned to that device is rescinded, and you may no longer provide an NHRIC or NDC number on the label of your device or on any device package.

Manufacturers looking to enter the US market with their devices must adhere to FDA requirements for a successful market entry. We recommend seeking guidance from an experienced Regulatory expert in the region for assistance. It is important to stay informed and ensure compliance with regulations.