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Medical Device Label Review

All medical devices marketed in the United States must comply with strict FDA labeling requirements. Non-compliance results in the product being deemed misbranded. LMG reviews your label and delivers a corrected, FDA-compliant version.
21 CFR Part 801IFU ComplianceISO SymbolsSince 2009
FDA medical device label review — non-compliant vs compliant label comparison under 21 CFR Part 801
21 CFR Part 801
LMG compares your existing device label against FDA requirements and delivers a corrected, ready-to-use compliant version.

About FDA Medical Device Label Review

All medical devices marketed in the United States must comply with strict FDA labeling requirements. Non-compliance results in the product being deemed misbranded. Our services help you navigate the complexities of labeling, IFU, and packaging graphics.

Our regulatory specialists provide expert guidance in:

  • Identification of device class, product code, and regulation number
  • Verifying if your device requires a 510(k) clearance or is exempt
  • Review of mandatory contents required on labels and packaging
  • Assessment of marketing and promotional statements
  • Overall label format, layout, and presentation

At Liberty Management Group, our experienced professionals conduct a detailed review, identify compliance gaps, and deliver a revised, ready-to-use FDA-compliant label—accurately, efficiently, and cost-effectively.

21 CFRPart 801
IFUReviewed
7–10 daysTurnaround
From $649LMG Fee

Frequently Asked Questions

Common questions about this FDA label compliance service.
Review ensures the device is not misbranded, claims are consistent with cleared indications, users receive adequate instructions, and risks/warnings are clearly communicated.
  • Device name and intended use
  • Indications for use
  • Manufacturer name and address
  • Warnings, precautions, and contraindications
  • Instructions for Use (IFU)
  • ISO symbols and abbreviations
A device is misbranded if labeling is false/misleading, required info is missing, claims exceed regulatory definitions, or directions for use are inadequate. Misbranding leads to recalls and import holds.

Intended Use: The general purpose or function of the device.
Indications for Use: The specific diseases, conditions, or patient populations the device is intended to treat or diagnose.

It provides regulatory readiness, reduces inspection risks, avoids FDA warning letters, and prevents costly port detentions.
FDA medical device label review — non-compliant vs compliant label comparison under 21 CFR Part 801

Example: Non-compliant vs. Corrected Label

Ready to Register Your Device Label?

Simply contact our regulatory team to guide you through the next steps.

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