What The FDA’s New Low-risk Device Guidance Means For Med Tech Marketers
FDA Low-Risk Device Guidance: What It Means for MedTech Marketing, Claims, and Go-To-Market Strategy
How medtech brands in the health and wellness space can grow confidently—without crossing regulatory lines
In January 2026, the FDA released an updated General Wellness: Policy for Low Risk Devices guidance. While positioned as regulatory clarification, this update has meaningful implications for medtech marketing strategy, advertising and promotion, and go-to-market execution—especially for companies operating at the intersection of health, wellness, and medical technology.
Here’s a link to download the full report: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices
For medtech marketers, founders, and commercial leaders, this guidance answers a critical question:
How do you build demand, differentiate your brand, and scale growth—while staying firmly within FDA boundaries?
At The Matchstick Group, we work with multiple companies that fall into the low-risk and general wellness category. What these brands are challenged with is how to capitalize on their innovations strategically and communicate value compliantly.
This is where strong medtech marketing strategy matters.
Why the FDA’s Low-Risk Device Guidance Matters to MedTech Marketers
The updated FDA guidance reinforces a foundational truth that many medtech companies underestimate:
Intended use is defined not just by the product—but by your marketing.
The FDA explicitly ties regulatory status to:
- Labeling and claims
- Advertising and promotional language
- User interface and user experience
- Digital marketing, websites, and apps
In other words, marketing teams now play a central role in regulatory risk management and commercial success.
For brands in the health and wellness space, this creates both responsibility and opportunity.
What Qualifies as a Low-Risk General Wellness Device?
Under the guidance, products may be considered low-risk general wellness devices if they:
- Promote or encourage a healthy lifestyle (e.g., mobility, balance, fitness, relaxation, sleep)
- Help users “live well with” certain chronic conditions without diagnosing or treating disease
- Are non-invasive, non-implanted, and pose minimal safety risk
Claims That Enable Growth (and Claims That Create Risk)
Permissible Wellness Claims
Medtech companies in this category can confidently build marketing around claims such as:
- Improving general mobility, balance, or movement
- Enhancing function, confidence, or daily living
- Supporting relaxation, sleep quality, or stress management
- Encouraging healthy habits and lifestyle behaviors
These claims allow brands to compete on outcomes that matter to users—without triggering unnecessary regulatory burden.
Claims That Undermine Go-To-Market Strategy
Where we see brands get into trouble is when marketing drifts into clinical territory:
- References to diagnosis, treatment, or disease management
- Use of clinical thresholds, alerts, or alarms
- Claims of “medical-grade,” “clinically equivalent,” or substitution for FDA-cleared devices
- Language that implies therapeutic intervention
For companies whose technologies may meaningfully improve quality of life—the challenge is not dumbing down the story. It’s telling the right story, the right way.
Go-To-Market Strategy Shift #1: Lead With Function, Not Pathology
Many medtech brands default to medicalized messaging—even when their products are designed for wellness use.
The FDA guidance reinforces a smarter commercial approach:
- Emphasize function over disease
- Talk about real-world use, daily integration, and consistency
- Frame benefits in terms of independence, confidence, and quality of life
This approach doesn’t weaken differentiation—it strengthens it, particularly in consumer-facing and wellness-adjacent channels.
Go-To-Market Strategy Shift #2: Build a Compliant Claims Architecture
High-performing medtech brands treat claims as a strategic system, not a one-off exercise:
- Core claims that anchor brand positioning
- Audience-specific claims tailored to consumers, clinicians, or caregivers
- Clear guardrails that define what not to say
This structure allows marketing teams to scale content, advertising, and sales enablement quickly—without re-litigating compliance at every turn.
Go-To-Market Strategy Shift #3: Align Strategy, Creative, and Execution
One of the FDA’s clearest signals is that inconsistency creates risk.
Your:
- Website
- Digital advertising
- Sales materials
- App language and UX
- Social and content marketing
All contribute to intended use.
That’s why medtech companies need more than a regulatory review—they need a marketing partner who understands strategy, compliance, and execution equally well.
The Strategic Opportunity for Health & Wellness MedTech Brands
For low-risk device companies, this guidance is not a constraint—it’s a green light.
A green light to:
- Compete on experience, design, and engagement
- Build trust without overclaiming
- Expand access and adoption without unnecessary regulatory friction
Brands that win in this space don’t play it safe—they play it smart.
Why This Matters—and Where Matchstick Fits
At The Matchstick Group, we specialize in medtech marketing for companies operating within complex regulatory environments, including health and wellness-focused devices.
We help brands:
- Define compliant, differentiated positioning
- Build go-to-market strategies that scale
- Execute advertising and promotion brilliantly—within the lines
With the right strategy, the right claims, and the right execution, wellness-oriented medtech companies can unlock meaningful growth—confidently and compliantly.
If you’re building a medtech brand in the health and wellness space and want to ensure your go-to-market strategy is both bold and compliant, we’re always happy to compare notes.
FAQ: FDA Low-Risk (General Wellness) Devices and MedTech Marketing
What is the FDA’s “general wellness” policy for low-risk devices?
The FDA’s guidance explains when a product that promotes a healthy lifestyle (a “general wellness product”) may fall under a low-risk policy approach—meaning FDA generally does not intend to examine it to determine device status or enforce certain device requirements, as long as it fits the scope described in the guidance.
What makes a product a “general wellness product” under the guidance?
In plain English, the guidance describes two factors:
- Intended use is only general wellness (maintaining/encouraging a general state of health or healthy activity), and
- The product presents low risk to users.
What kinds of claims are generally “safe” for low-risk wellness positioning?
The guidance includes examples of general wellness claim areas such as:
- weight management
- physical fitness / activity
- relaxation or stress management
- sleep management
- mental acuity
- self-esteem
- sexual function
A key marketing takeaway: these claims are framed as general improvement and not tied to diagnosing, curing, mitigating, preventing, or treating disease.
Can marketers mention diseases or conditions at all?
Sometimes—but carefully. The guidance describes a category where products may reference certain chronic diseases/conditions only in the context of healthy lifestyle choices and phrased as “may help reduce the risk of” or “may help living well with” (and only where the lifestyle-disease relationship is well understood and generally accepted).
What claims or features tend to push a product out of “general wellness” and into medical device territory?
The guidance flags several red-zone areas for labeling, advertising, UI, and functionality—especially:
- claims tied to diagnosis, screening, monitoring, alerting, or management of a disease/condition
- clinical thresholds or “abnormal/pathological” language
- alerts/alarms/prompts recommending specific clinical action or medical management
- claims like “medical grade,” “clinically equivalent,” or substitutes for an FDA-authorized device
How does the FDA think about wearables or sensors that output physiologic parameters?
The guidance notes some products using non-invasive sensing to estimate or output physiologic parameters may still fit within general wellness—if outputs are intended solely for wellness, don’t drive clinical action, don’t claim to substitute for cleared/approved devices, and (when relevant) aren’t mimicking clinical values unless validated appropriately.
What makes a product “not low risk” under this guidance?
The guidance includes a simple risk screen. If any of these are true, it’s not low risk:
- invasive
- implanted
- uses an intervention/technology that may pose safety risk without specific regulatory controls (examples include certain lasers/radiation; the guidance also gives examples like neurostimulation being higher risk in this context)
What’s the biggest implication for medtech advertising and promotion?
Consistency is everything. The guidance emphasizes that labeling and promotional materials should be consistent with, and not exceed, the stated intended use. Translation for marketers: your website copy, paid ads, decks, app onboarding, UI language, FAQs, and social content all become part of how intended use is interpreted—so your claims system and review workflow need to be built to scale.
How should health & wellness medtech companies rethink go-to-market strategy in light of this guidance?
A strong approach is to build a claims architecture that supports growth within the lines:
- Core wellness claims (broadly usable, durable across channels)
- Audience-specific supporting claims (consumer vs. clinician vs. partner)
- Guardrails + red-flag language list (what not to say, what not to imply)
- UX/UI copy standards (so product language doesn’t accidentally create clinical intended use)
