Imagine being in the middle of a pitch, and an investor asks, "Have you considered your 510(k) pathway?"
You freeze. You've heard the term, and you think you know what it means. But you're not entirely sure, and admitting uncertainty feels risky.
Welcome to FemTech regulatory terminology: the language everyone assumes you speak, but no one actually explains.
Let’s break down the terms every FemTech founder should understand, not to become a regulatory expert, but to know where you stand and what questions to ask.
Why Should You Learn This
The FDA regulates medical devices to protect public safety. If your product makes medical claims, like diagnosing conditions, treating symptoms, or guiding clinical decisions, you're in FDA territory.
The key principle: Your regulatory pathway isn't optional. It's determined by your product's intended use, which is the purpose you claim it serves.
Get this wrong, and you could launch without required clearance, spend unnecessarily on the wrong pathway, or scare off investors who see regulatory confusion as a red flag.
Medical Device vs. Wellness Product
This is the foundational question.
Wellness Product: Supports general health without making medical claims. Tracks lifestyle, provides education, helps users make informed decisions.
Examples: A period tracker that predicts cycle dates or educational content about menopause.
Regulatory requirement: Generally none, as long as you don't cross into medical claims.
Medical Device: Diagnoses, treats, prevents disease or affects body structure/function.
Examples: an app claiming to detect PCOS, a wearable measuring fertility hormones for clinical use, and a platform quantifying menstrual blood loss for diagnosis.
Regulatory requirement: FDA clearance or approval, depending on risk.
The grey zone: Most FemTech lives here. The difference between "track your cycle to understand patterns" (wellness) and "detect irregular cycles indicating PCOS" (medical) determines your entire regulatory strategy.
Device Classifications: Class I, II, III
Once you're a medical device, the FDA classifies you by risk level.
Class I (Low Risk): Lowest risk, with simpler controls. Usually exempt from premarket review. Example: Some menstrual cups.
Class II (Moderate Risk): Most FemTech medical devices land here. They require more controls to ensure safety and usually need 510(k) clearance.
Examples: apps providing clinical measurements, fertility monitors with diagnostic claims, and menstrual blood quantification tools.
Class III (High Risk): Life-sustaining devices or those with significant risk. Requires rigorous Premarket Approval (PMA). Very few FemTech products fall here.
510(k): The Pathway Most FemTech Devices Take
510(k) stands for Section 510(k) of the Federal Food, Drug, and Cosmetic Act.
It is a premarket submission to the FDA demonstrating that your device is "substantially equivalent" to a legally marketed device already on the market (called a predicate device).
How it works:
You identify a predicate device (something already cleared with similar intended use and technology)
You demonstrate your device is as safe and effective as the predicate
The FDA reviews and either clears your device or requests more information
What "substantially equivalent" means:
Same intended use
Similar technological characteristics
Same level of safety and effectiveness
Note that 510(k) clearance ≠ FDA approval
"Cleared" means substantially equivalent to an existing device.
"Approved" (PMA) means the FDA evaluated clinical data and approved it as safe and effective.
When investors or partners ask, "Are you FDA cleared?" this is usually what they mean.
De Novo: For Novel Low-to-Moderate Risk Devices
This is the pathway for innovative devices with no existing predicate but low-to-moderate risk.
You’d use it when your device is genuinely novel, i.e. nothing like it exists, but it's not high-risk enough to need PMA.
Timeline: 150 days for review (plus extensive preparation time)
De Novo is for true innovation. If a predicate exists, 510(k) is faster and cheaper.
PMA
This is required for Class III high-risk devices, and it involves clinical trials demonstrating safety and effectiveness.
Very few FemTech products require PMA. If someone suggests you need it, get a second opinion.
Intended Use: The Most Important Phrase
This is the general purpose of your device, as you define it, and it determines your regulatory pathway. Not what your device can do, but what you say it's for.
Look at your website, app store description, and marketing materials. What are you telling users your product does? That's your intended use, and it determines your regulatory fate.
Where Do You Stand? The Decision Tree
Step 1: What do you claim your product does?
General wellness, tracking, education → Likely no FDA review
Diagnosis, treatment, clinical measurement → FDA pathway needed
Step 2: If medical device, what's the risk?
Low risk → Class I (likely exempt)
Moderate risk → Class II (likely 510(k))
High risk → Class III (PMA required)
Step 3: Is there a similar device on the market?
Yes → 510(k) pathway
No, but low-moderate risk → De Novo
No, and high risk → PMA
Step 4: Are you sure about Steps 1-3?
Yes, we've consulted experts. → On the right track
We think so, but haven't confirmed. → Need regulatory guidance before launch
Honestly, we're guessing → Stop. Get help. Don't launch yet.
Common Mistakes Founders Make
"We'll figure out regulation after launch." If you need clearance and don't have it, launching publicly can trigger FDA enforcement.
"Our competitor doesn't have clearance, so we don't need it." Your competitor might be taking a risk or about to get an FDA warning letter. Their status doesn't determine yours.
"We're just wellness, so regulation doesn't apply." Check your claims. If you're implying medical utility even subtly, you might have crossed the line.
"Regulation is too expensive, so we'll stay vague." Vague claims don't protect you. The FDA evaluates intended use based on how a reasonable person would interpret your marketing.
In Summary
You don't need to become a regulatory expert. But you do need to know:
Are you building a medical device or wellness product?
If medical, what class and pathway apply?
What are you claiming, and does it match your regulatory strategy?
These aren't questions to answer "eventually." They're foundational decisions that affect what you can legally claim, how much regulatory work you're facing, whether investors see you as credible, and whether your launch will be smooth or disruptive.
The founders who succeed are the ones who understand regulation early, plan for it strategically, and build it into their roadmap from the start.
Get clear on where you stand. Then build accordingly.
Dr. Ayomide Owodunni is a FemTech Credibility Advisor helping FemTech founders build products that can withstand regulatory scrutiny and investor due diligence before they make expensive mistakes.
Brand Spotlight: Kasha
Kasha (Rwanda, East & Southern Africa) is a digital platform enabling women to discreetly access menstrual, sexual, and reproductive health products via mobile, SMS, agents, and last-mile delivery, solving stigma-driven access gaps.
They’re differentiated by offline-first distribution and trusted local agents and successfully scaled from $1M to $50M in revenue, serving millions of low-income women.
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