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FDA Medical Device Labeling & Packaging Control
If your medical device company plans to market devices in the United States, you must comply with the FDA Quality System Regulation (QSR) requirements for Labeling and Packaging Control, as outlined in 21 CFR Part 820.120.
The primary objective of these controls is to ensure that medical device labels are accurate, properly designed, and correctly applied to the appropriate products—reducing the risk of mislabeling, mix-ups, and patient harm.
FDA Requirements for Medical Device Labeling Control
Under 21 CFR 820.120, medical device manufacturers are required to establish and maintain written procedures to control all labeling activities. These procedures must ensure that labeling meets regulatory requirements and is consistently applied throughout manufacturing and distribution.
The regulation mandates five key types of labeling controls:
1. Label Integrity
Medical device companies must ensure that labels:
Remain legible
Stay securely affixed
Withstand normal storage, handling, shipping, and use conditions
A label that becomes unreadable or detaches during distribution does not meet FDA requirements—even if the content itself is compliant.
2. Labeling Inspection
Before labels are used, they must be examined for accuracy. This inspection must verify that all required information is correct, including:
Unique Device Identifier (UDI)
Expiration date
Lot or control number
Storage and handling instructions
Indications for use
Any required warnings or regulatory statements
This inspection must be documented in the Device History Record (DHR), including the date of review and approval signature.
3. Labeling Storage
Manufacturers must implement labeling storage systems that:
Clearly identify different labels
Prevent label mix-ups
Protect labels from damage or loss
Proper storage controls reduce the risk of incorrect labels being applied to the wrong device.
4. Labeling Operations
Labeling operations must be controlled to ensure:
Correct labels are applied to the correct devices
Mix-ups are prevented during production
The Device History Record (DHR) must document the specific labels used for each production unit, lot, or batch.
5. Control Numbers
Medical devices subject to traceability requirements under 21 CFR 820.65 must be labeled with a control number that allows tracking from manufacturing through distribution.
Control numbers support:
Product recalls
Adverse event investigations
Supply chain traceability
Medical Device Label & QSR Review Services
FDA Registration Assistance provides professional medical device labeling and QSR review services to help ensure your products comply with FDA labeling and packaging control requirements.
Our services help:
Identify labeling compliance gaps
Review label content and durability
Assess labeling procedures and documentation
Reduce the risk of FDA inspection findings or enforcement actions
To have FDA Registration Assistance review your medical device products and labeling for FDA compliance, please contact us today.
Frequently Asked Questions (FAQ)
What regulation governs medical device labeling control?
Medical device labeling and packaging controls are governed by 21 CFR Part 820.120 under the FDA Quality System Regulation (QSR).
Who must comply with FDA medical device labeling controls?
Any manufacturer, packer, or distributor of medical devices intended for the U.S. market must comply with FDA labeling requirements.
What is a Device History Record (DHR)?
A DHR is a required record that documents the production history of a device, including labeling used for each unit, lot, or batch.
Does labeling control include UDI requirements?
Yes. Labeling inspections must verify that the Unique Device Identifier (UDI) is accurate and correctly applied when required.
What happens if my labeling is not compliant?
Non-compliant labeling may result in:
FDA Form 483 observations
Warning letters
Product recalls
Detention or refusal of devices
Regulatory enforcement action
Can FDA Registration Assistance review existing labels and procedures?
Yes. FDA Registration Assistance can review existing labels, labeling procedures, and documentation to help ensure compliance with FDA QSR requirements.
Contact FDA Registration Assistance
Ensure your medical device labeling meets FDA Quality System Regulation requirements.
