What you can and can't say about your AI medical device

In the world of AI medical devices, it’s easy to get carried away with bold claims. Companies want to highlight the life-changing potential of their innovations, investors want strong messaging, and let’s be honest – “groundbreaking” sounds far more exciting than “substantially equivalent.” But in an industry where patient safety and regulatory compliance are non-negotiable, making unverified or misleading claims isn’t just bad practice – it can lead to hefty fines, product recalls, and serious reputation damage.

I saw this sort of over-hyped marketing in full force and at it’s most egregious at RSNA in 2024, with multiple vendor booths advertising unregulated products. So, it’s comforting to see the FDA has stepped in to issue new guidance: Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products. A nice, snappy title. This document outlines how companies can share scientific information about unapproved uses of their medical products without crossing the line into promotional claims that could suggest a new intended use. 

The goal is to give healthcare providers (HCPs) access to relevant scientific insights while ensuring that communications remain transparent, evidence-based, and compliant with regulatory requirements. The guidance serves as an enforcement policy rather than a legally binding regulation, meaning that while firms are not required to follow it, those who do can have greater confidence that their communications will not be used as evidence of a new intended use.

Fortunately enough for you, we read the entire 32-page document so you don't have to (even though we definitely recommend that you do). We have identified the key elements of the guidance to help you better understand your responsibilities and navigate these regulations with confidence…

Balancing information access and safety

The FDA acknowledges the value of giving healthcare providers access to scientific insights about unapproved uses of medical products, empowering them to make well-informed decisions for patient care. However, this access cannot compromise the integrity of the premarket approval system, which is designed to ensure that medical products meet stringent safety and efficacy standards before reaching patients. 

Communications must be truthful, clear, and non-misleading, avoiding any confusion about a product’s regulatory status or safety profile. This approach protects both patient trust and the regulatory process. Importantly, the FDA reassures companies that sharing scientific information on unapproved uses (SIUU) in line with its guidance will not, in itself, be considered evidence of a new intended use.

Source publications and transparency

SIUU communications must be built on a foundation of credible, scientifically robust evidence. To ensure credibility, information and data should be from trusted sources such as peer-reviewed journal articles, clinical practice guidelines, or company-generated materials that meet stringent editorial and methodological standards.

Transparency is also equally as important. Companies should clearly disclose any affiliations or financial ties between the publication’s authors and the company to ensure the integrity of the information. By addressing potential biases upfront, companies can maintain trust with healthcare providers and reinforce that the information they share is both reliable and ethical.

Content and risk disclosures

To maintain clarity and compliance, companies are required to separate promotional materials for approved uses from communications about unapproved uses. Promotional materials can include product brochures, advertisements, sales presentations, websites, social media content, and any marketing campaigns aimed at driving adoption of an approved product. Any overlap risks misleading healthcare providers and eroding the integrity of the regulatory process. In addition, each communication must clearly state the product’s FDA approval status, explicitly mentioning that unapproved uses are not proven safe or effective.

Equally, companies are expected to provide comprehensive details on risks, contraindications, and limitations, including any serious or life-threatening safety concerns outlined in FDA-required labelling. This transparency should extend to providing HCPs with access to the most up-to-date labelling information, either by including it directly in the communication or providing a clear and accessible way to obtain it.

Practical limits for company communications

The new guidance establishes clear boundaries on how companies can discuss unapproved use. This is to ensure communications do not mislead healthcare providers about a product’s safety or efficacy. Calls to value, such as product claims or implying direct patient benefit or making unsupported claims are strictly off-limits, as they risk creating false impressions about a product’s capabilities and undermine informed clinical decisions.

Instead, companies are encouraged to use neutral, fact-based language that directs HCPs to relevant studies or data without suggesting specific outcomes. To maintain transparency, all communications must include disclaimers clearly stating that the unapproved use has not been reviewed or approved by the FDA, along with any necessary context about the product’s regulatory status.

Conclusion

The FDA’s guidance offers companies a chance to build trust with healthcare providers by presenting clear, evidence-backed information that prioritises transparency and patient safety. We think the guidance is fair, and ultimately applicable to all regulatory jurisdictions, and advise AI companies worldwide to abide by them. By adhering to these principles, organisations not only empower HCPs to make informed decisions but also reaffirm their commitment to ethical communication and the integrity of the regulatory process. This ensures that the advancement of medical knowledge goes hand in hand with safeguarding public health.

This guidance represents the FDA’s enforcement policy and current thinking on this topic. It does not establish any rights for any person and is not binding on FDA or the public. The FDA emphasises that following these recommendations ensures companies won’t face regulatory action solely based on disseminating such communications.

Hardian’s Do’s and Don’ts

If all of the above still feels like a lot to digest, don’t worry – we’ve got you covered. To make things easier, we’ve distilled the key points into a simple ‘Do’s and Don’ts’ table. Use it as your quick reference guide to staying on the right side of the regulators (but again, please do read the full FDA guidance).

Do's
Ensure all communications are truthful, non-misleading, and provide enough information for HCPs to evaluate the strengths, weaknesses, and validity of the scientific information. e.g. provide links to peer reviewed publications that demonstrate performance of your device within its intended use Use scientifically sound, peer-reviewed source publications that meet accepted standards and avoid those refuted or retracted by credible evidence. Include key disclosures, such as: That the unapproved use is not FDA-approved and its safety and effectiveness are unproven. The FDA-approved uses, limitations, precautions, and serious risks of the medical product. Author affiliations or financial ties to the firm. Study details (design, methodology, results, limitations) if not included in the source publication. The publication date of any referenced material. Make disclosures clear and prominently visible. e.g. actively put disclosures on all marketing materials, including your website and any external presentations or promotional materials. Keep SIUU communications separate from promotional content for approved uses. Train personnel sharing SIUU communications to ensure they understand and comply with these guidelines. e.g. make sure your sales team is appropriately trained in how to communicate scientific evidence, and not conflate it with anecdotal evidence

Dont's

Don’t share false, misleading, or incomplete information, or use publications that fail to meet accepted standards, include fraudulent data, or have been refuted or retracted. Don’t combine unapproved use information with promotional content for approved uses. e.g. make it explicit that certain functions have not undergone FDA review and are for research use only until then. Refrain from altering or abridging reprints, misrepresenting findings, or overstating results in clinical reference resources. Avoid firm-generated presentations that: Imply broader applicability of study results than supported. Present unsupported conclusions or distort data with misleading statistics or techniques. Use promotional elements like endorsements, taglines, or emotional appeals. Pre-judge product benefits for individual patients.

Hardian Health is a clinical digital consultancy focused on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.