Device Labeling Requirements and Content for Premarket Approval Applications

What You Need to Know? 👇

What are the key differences between warnings and precautions in medical device labeling?

Warnings describe serious adverse reactions and potential safety hazards requiring immediate attention, while precautions include special care instructions for safe and effective device use, such as protective wear requirements or monitoring recommendations.

How should contraindications be determined and documented for medical devices?

Contraindications describe situations where device use is prohibited because risks clearly outweigh benefits. Only known hazards should be listed, not theoretical possibilities. If no contraindications are known, state “None known.”

What labeling requirements apply specifically to prescription medical devices?

Prescription devices must include the federal restriction statement, method of application, comprehensive use information including indications and hazards, and the date of labeling issuance or latest revision on all materials except labels and cartons.

When is patient information labeling required for medical devices?

Patient information labeling is appropriate when patients should know about alternatives, substantial risks exist, strict adherence to treatment is required, or public controversy surrounds the device. Content should use seventh-grade reading level terminology.

What constitutes misbranding in medical device labeling according to FDA regulations?

Misbranding occurs when labeling is false/misleading, lacks required manufacturer information, doesn’t prominently display necessary warnings, lacks adequate directions for use, or includes unauthorized representations suggesting FDA approval without proper authorization.

How should adverse reactions be organized and presented in device labeling?

Adverse reactions should be listed in descending order by clinical significance (severity and frequency). Include all reactions reasonably associated with device use, provide frequency data when helpful for decision-making, and reference other labeling sections for additional information.

---

What You Need to Do 👇

Recommended Actions

1. Review and ensure all required labeling sections are included (Indications, Contraindications, Warnings, Precautions, Adverse Reactions)
2. Verify labeling content meets readability requirements and uses appropriate terminology
3. Ensure prescription device labeling includes all required statements and restrictions
4. Review and remove any inappropriate disclaimers or suggestions of FDA approval
5. Develop patient information labeling when appropriate based on risk factors
6. Verify all safety information is properly organized and presented
7. Ensure labeling includes appropriate information for special patient populations
8. Review and confirm accuracy of all manufacturer information and content statements
9. Verify compliance with restricted device requirements if applicable
10. Document justification for any deviations from standard labeling requirements

Key Considerations

Human Factors

• Patient information labeling should not exceed seventh grade reading comprehension level
• Technical terms should be kept to minimum and defined when necessary

Labeling

• Must include manufacturer name, place of business, and accurate quantity statement
• Required information must be prominently placed and easily readable
• Must include adequate directions for use and warnings
• False or misleading labeling is prohibited
• For prescription devices, must include “Caution: Federal law restricts…” statement
• Must include indications for use, contraindications, warnings, precautions, and adverse reactions
• Should include information about special patient populations and limitations

Safety

• Must describe serious adverse reactions and potential safety hazards
• Include appropriate warnings when reasonable evidence of serious hazards exists
• List adverse reactions in order of clinical significance
• Include precautionary information about protective wear and monitoring requirements

Other considerations

• Disclaimers regarding safety and effectiveness should be avoided
• Cannot include representations suggesting official FDA approval
• For restricted devices, additional labeling requirements apply regarding sale and distribution restrictions

---

Relevant Guidances 🔗

• Labeling Requirements and Recommendations for Medical Devices
• Writing Medical Device Patient Labeling: Content and Design Considerations

---

Original guidance

• Device Labeling Requirements and Content for Premarket Approval Applications
• HTML
• Issue date: 1991-03-07
• Last changed date: 2020-03-17
• Status: FINAL
• Official FDA topics: Medical Devices, Labeling, Premarket
• ReguVirta ID: a3d74ec2709dbdbbd7ecaffcef61f52c