For light therapy devices, performance alone is not enough. How a device is positioned and what it claims to do must be supported by appropriate clinical evidence. Regulators, distributors and professional buyers increasingly expect claims to be credible, documented and proportionate to the available data.

Understanding the relationship between clinical evidence and claims is essential for brands that want to enter regulated markets without delays, rejections or forced relabeling.

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What Counts as a “Claim” in Light Therapy

A claim is any statement that describes what a device does or what benefit it provides. This includes:

• website content and product pages
• user manuals and instructions for use
• marketing materials and brochures
• training materials for professionals

In light therapy, claims can quickly shift a device from a general wellness category into regulated medical territory. Statements related to treatment, recovery, prevention or physiological effects typically trigger higher regulatory scrutiny.

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The Role of Clinical Evidence

Clinical evidence demonstrates that a device performs as intended and is safe for its claimed use. This evidence can come from:

• clinical investigations
• peer-reviewed scientific literature
• post-market clinical follow-up data
• equivalence to existing, well-documented devices

Under both MDR and FDA frameworks, claims must be proportionate to the strength and relevance of the evidence. Stronger claims require stronger clinical justification.

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Clinical Evidence Under MDR

The European Medical Device Regulation places significant emphasis on clinical evaluation. Manufacturers must show a clear link between:

• intended use
• claimed benefits
• clinical data

MDR requires a structured Clinical Evaluation Report (CER) that is kept up to date throughout the device lifecycle. For light therapy devices, this often includes a critical review of photobiomodulation literature, biological mechanisms, and application-specific studies.

Unsupported or exaggerated claims are a common reason for regulatory delays or negative notified body feedback.

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FDA Expectations for Claims and Evidence

In the United States, the FDA evaluates claims primarily through the lens of intended use and labeling. Claims influence:

• device classification
• required approval pathway
• depth of performance and safety testing

For 510(k) submissions, claims must align closely with those of the predicate device. Claims that deviate significantly, whether through novel technology, new indications, or expanded therapeutic scope, may require alternative pathways such as De Novo (for new device types) or PMA (for higher-risk applications), both of which involve greater time and regulatory investment.

Clear, conservative claims supported by solid evidence often lead to smoother FDA reviews.

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Why Overclaiming Creates Risk

Overclaiming is one of the most common mistakes in light therapy product launches. It can result in:

• regulatory reclassification
• rejection or withdrawal of submissions
• forced changes to labeling and marketing
• loss of distributor or clinical trust

Aligning claims with evidence protects not only regulatory status, but also brand credibility in professional and consumer markets.

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Building Evidence and Claims Together

The most effective strategy is to develop clinical evidence and claims in parallel, not sequentially. This means:

• defining intended use early
• aligning R&D and regulatory strategy
• selecting studies and literature that support realistic claims
• ensuring consistency across all communications

When evidence and claims evolve together, regulatory review becomes more predictable and market entry more stable.

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Evidence-Driven Positioning in a Maturing Market

As the light therapy market matures, regulators and professionals are demanding greater scientific transparency. Devices that clearly communicate what they do and what they do not do are better positioned for long-term success.

At Light Tree Ventures, clinical strategy is integrated into device development from the earliest stages. Products are developed and manufactured within ISO 13485-certified quality systems, with regulatory and clinical expertise supporting claim definition, evidence selection, and documentation.

This approach ensures light therapy devices are positioned with credible, compliant claims that support regulatory approval, professional trust, and sustainable market access.

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Final Thoughts

Clinical evidence and claims are inseparable. In light therapy, what you say about a device must be supported by what you can prove.

Brands that align claims with evidence from the beginning reduce regulatory risk, protect credibility, and build products that stand up to scrutiny across global markets.

Because in regulated industries, trust is built not on promises, but on proof.

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References

• Gornall, J. et al. (2021). How Claims Shape Medical Device Regulation.
  BMJ
  https://www.bmj.com/content/372/bmj.n61
• International Medical Device Regulators Forum (IMDRF) – Clinical Evaluation Guidance
  https://www.imdrf.org/documents/clinical-evaluation

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