Wellness vs. Medical Device

In the FemTech space, there's a line that separates wellness products from medical devices. It's not always obvious, it's not always intuitive, and it's almost never where founders think it is.

Cross it accidentally, and you're facing regulatory scrutiny, costly pivots, and shaken investor confidence. Stay on the right side strategically, and you're building on solid ground.

This distinction is a framework that affects everything from your marketing copy to your fundraising strategy to your path to market. And in women's health, where trust is everything, getting this right from the start isn't optional; it's foundational.

Let's break down what this distinction actually means, who decides where products fall, and why it matters more than ever.

A medical device, according to the FDA, is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article" that is intended for use in:

In simpler terms: if your product makes claims about diagnosing, treating, preventing, or curing a medical condition, or if it affects how the body functions, it's likely a medical device.

A wellness product, on the other hand, doesn't have a formal FDA definition because it falls outside medical device regulation (although they may still be subject to consumer protection and advertising laws). These are products intended to support general health and well-being without making medical claims. They help you maintain health, track information, educate yourself, or support lifestyle choices, but they don't promise to fix, diagnose, or treat medical problems.

The key word in both definitions is intended use.

Intended use isn't just what you privately intend your product to do. It's what you communicate to users through:

Even if you design your product as a wellness tool, if you market it with medical claims, regulators will classify it as a medical device based on those claims.

This is why the same technology can be wellness or medical, depending entirely on how it's positioned.

So how do regulators actually decide which category your product falls into? They look at several key factors:

1. The claims you make

This is the biggest factor. Claims like "diagnoses PCOS," "treats period pain," or "cures hormonal acne" are medical claims that trigger medical device classification.

Claims like "helps you understand your menstrual cycle" or "supports your wellness journey" are wellness claims, as long as they don't promise medical outcomes.

2. The intended patient population

Are you targeting healthy people who want to maintain wellness? Or are you targeting people with diagnosed conditions, symptoms, or diseases?

3. The risk level

Regulators use risk-based thinking. The more risk your product poses to users if it malfunctions or provides incorrect information, the more likely it needs regulatory oversight.

4. The type of information or intervention provided

Is your product providing general educational information, or is it providing personalized medical advice, diagnoses, or treatment recommendations?

Wellness products in FemTech typically include:

Medical devices in FemTech include:

Multiple regulators may be involved depending on your product type and target markets:

In the United States: The FDA oversees medical devices through its Center for Devices and Radiological Health (CDRH), using a risk-based classification system (Class I, II, or III). The Digital Health Center of Excellence provides guidance on when software functions as a medical device.

In Europe: The EU MDR uses similar risk-based classification (Class I, IIa, IIb, III) with different criteria and requirements.

In the UK: The MHRA has its own framework post-Brexit, though it currently aligns closely with the EU MDR.

Other key regulators include Health Canada, Australia's TGA, Japan's PMDA, and China's NMPA. Each has slightly different definitions and thresholds, which is why global expansion requires market-specific regulatory strategies.

The FemTech market is growing rapidly, and regulators are paying closer attention. Investors are also getting smarter. And users are becoming more skeptical. After years of overpromising products, women want proof. They want credibility. They want to know the products they're trusting with their health are legitimate.

Due diligence now includes regulatory risk assessment. A company that doesn't understand its classification is a company with hidden liability. 

You can choose to position your product as wellness and avoid certain claims. You can choose to pursue medical device clearance and back up your claims with clinical evidence. What you can't do is ignore the distinction and hope no one notices.

Dear Founder, Take an honest look at your product marketing: website, app store description, pitch deck, and social posts. Are you making claims about diagnosing, treating, preventing, or curing conditions? If so, are you confident you're classified correctly and have the evidence to support those claims?

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Dr. Ayomide O is a FemTech Clinical Credibility Advisor helping founders, investors, and brands build women's health products on solid scientific and regulatory foundations.