There is a document that many FemTech founders have never written, many have never heard of, and almost everyone underestimates. It is not a pitch deck. It is not a terms and conditions page. It is not a privacy policy.

It is called an intended use statement, and if you are building a health product for women, it might be the most important document for your company.

Let me explain why.

What Exactly Is an Intended Use Statement?

Imagine you are building an app that helps women track their symptoms and understand their hormonal health. You know what it does. Your team knows what it does. But does a regulator know? Does an investor doing due diligence know? Does a clinician who receives a report generated by your app know?

An intended use statement is the document that answers, clearly and precisely, three questions: 

• what your product is designed to do
• who it is designed for, and 
• how it is meant to be used.

It is not marketing language. It is not a mission statement. It is a clinical and regulatory anchor; the foundation that everything else in your company, including your claims, your content, your validation strategy, and your regulatory pathway, should be built on.

Getting it wrong is one of the most expensive mistakes in FemTech. And getting it wrong is remarkably easy to do.

What Goes Into One?

A well-constructed intended use statement has several distinct parts. Here is what each one does and why it matters.

What the product actually is. Not what it does for users, but what it fundamentally is. A mobile app. A software platform. A combination of app and wearable. This sounds obvious, but it sets the category before any claims are made, and different categories are treated very differently by regulators.

Who it is for. This means being specific. Is your user a patient or a healthy individual? Are they using your product independently or under clinical supervision? What level of health literacy are they assumed to have? If your app generates reports that are seen by both users and clinicians, both audiences need to be described, because a clinician-facing tool carries different accuracy and liability expectations than a consumer-facing one.

What it is designed to do. This is the heart of the statement, and every word carries real weight. Consider how different these three phrasings are:

• “Provides general educational information about the menstrual cycle” — minimal regulatory concern
• “Helps users identify patterns in their cycle that may be worth discussing with a healthcare provider” — moderate regulatory consideration
• “Identifies symptoms consistent with gynaecological conditions to support clinical diagnosis” — significant regulatory implications

Same product, potentially. Very different regulatory realities depending on how you describe it.

The specific conditions it addresses. If your app covers PCOS, endometriosis, or perimenopause, those should be named. Vagueness here does not protect you. It just makes your statement less useful when questions arise.

Who should not use it. This is the section most FemTech founders skip, and it represents some of the highest liability exposure. A meaningful contraindications section is not a single line saying “consult your doctor.” It reflects genuine thinking about who the product is not appropriate for, when it should not be used alone, and what it cannot safely replace.

Where it will be used. Home use and clinical use carry different expectations. If your product lives in both environments, that needs to be acknowledged.

What it is not designed to do. This dedicated section explicitly states the boundaries of your product. Not in the fine print of your terms and conditions, but clearly in the intended use statement itself. If your product is designed to support diagnostic conversations but not to diagnose, that distinction must be stated explicitly and unambiguously.

The evidence behind your claims. What does your product claim to do accurately? What evidence supports that? If you cannot answer this question, that tells you something important about the state of your product before anyone else has to tell you.

Why Founders Get This Wrong

The most common mistake is vagueness. Statements like “to improve women’s health and wellness” sound harmless, but they tell regulators, investors, and clinicians nothing about what the product actually does. And vagueness is not a regulatory shield. It is a liability.

The second most common mistake is contradiction. A company writes an intended use statement that says “general wellness information only,” but the product generates condition-specific symptom reports or scores users against diagnostic criteria. Regulators look at what the product does, not what the statement claims it does. The functionality always wins.

The third mistake is relying too heavily on disclaimers. Some founders write broad intended use statements and then add aggressive disclaimers to offset them. But disclaimers do not override functionality. If your product does something that requires regulatory approval, a disclaimer saying it is not a medical device does not make that true.

Why This Matters for You Right Now

If you are a FemTech founder, your intended use statement is not a document for later. It is not something to write when regulators come knocking. It is the document that shapes every health claim you make, every partnership you pursue, and every investor conversation you have.

A product that knows precisely what it is, who it is for, and what it does and does not claim to do is a product that can be reviewed, validated, and defended.

A product that has not answered those questions is building on unstable ground, regardless of how good the technology is.

If you do not have an intended use statement, writing one is one of the most valuable things you can do for your company this month. And if you have one, it is worth reviewing against every component above because in FemTech, credibility is not just a nice to have. It is your competitive advantage.

NB

This article is a summary. The full guide, covering every component, examples of well-constructed statements, and the red flags to watch for, is now live on the website. Read it here.

I’ve built a free toolkit for FemTech founders.

The FemTech Red Flag Readiness Checklist is a free 5-minute self-assessment designed to help founders evaluate whether their product can actually detect when something may be going wrong for the women using it. 

It walks through seven critical safety areas, from evidence-based safety thresholds to whether alerts make sense to a real user under stress, and whether safety is treated as an ongoing responsibility. If your product interprets women’s health data,

This checklist will show you where you stand and what to fix first. You can access it through this link.