Live webinar on Feb.2 at 4:30 p.m. CET.
Wellness or Medical Device? Here’s what the new FDA guidance says.
Webinar speaker: Dr. Jonas Walter & Dr. Michaela Kauer-Franz, both experts on international usability engineering.
Does this sound familiar?
Your product started out as a wellness solution – or at least that was the plan.
Design and development are moving forward, features are being added, and the roadmap is ambitious.
At the same time, questions start to come up:
Is this still a general wellness product?
Are some claims already health-related?
Could certain features be interpreted as diagnostic or therapeutic?
And how would the FDA look at this today?
Uncertainty grows. Decisions are postponed, claims are adjusted, and features are debated – often late in development, when changes are costly.
This is exactly where our webinar comes in.
We’ll explain what the FDA’s updated General Wellness: Policy for Low Risk Devices guidance means in practice – and how to assess, early and realistically, whether your product remains a wellness product or is moving toward medical device regulatory scope.
Topics covered in the webinar:
In this webinar, you will gain a structured, practical overview of how the FDA’s updated General Wellness: Policy for Low Risk Devices guidance applies to real products – and how to assess borderline cases during ongoing development:
- What the FDA’s updated interpretation means for general wellness products, including apps, wearables, and digital health solutions
- How the FDA distinguishes between general wellness intent and medical device intended use – and why this distinction is not based on a single claim or feature
- Which product characteristics and features typically trigger medical device regulatory scope (e.g. diagnostics, clinical interpretation, closed-loop logic)
- How claims, UX wording, and product behavior interact in the FDA’s regulatory assessment
- Real-world examples of cutting-edge wellness and medical devices.
The Details:
When is the webinar, "Wellness or Medical Device? Here's what the new FDA guidance says," taking place?
The webinar takes place on February 2 at 4:30 p.m. CET.
Can I ask questions?
Yes, of course. There will be plenty of time for discussion.
How long will the webinar last?
The webinar will last approximately 60 minutes incl. questions.
Who should attend the webinar?
This webinar is ideal for product, UX, development, and regulatory professionals working on wellness products, digital health solutions, or borderline products who need to assess – or reassess – whether their product remains a general wellness product or falls within medical device regulatory scope.
It is especially relevant for teams who:
- are developing apps, wearables, or software-based health products,
- are making classification decisions during ongoing development,
- want to avoid unintended medical claims in product features, UX, or marketing,
- need a shared understanding across product, UX, regulatory, and marketing.
- want to see if their device might now classify as general wellness device.
What is the language of the webinar?
The webinar will be held in English.
Who are the speakers - Dr. Jonas Walter & Dr. Michaela Kauer-Franz?
Dr. Jonas Walter is a regulatory usability expert with over 10 years of experience. Key points:
- Head of Operations at Custom Medical
- Expert for International Usability Engineering strategy and application
- Hands-on experience with IVDs, medical devices and combination products from low to high-risk in more than 80 international projects
- Trainer of usability engineering at MedicalDeviceHQ.
Dr. Michaela Kauer-Franz is a usability expert with over 20 years of experience. Key points:
- CEO of Custom Medical, with locations in Germany and the US.
- Over 400 successfully completed medtech projects. This includes approximately one user study per week.
- TÜV-certified usability expert for medical devices
- Trainer of usability engineering at MedicalDeviceHQ.
- Author and speaker.
Register for “Wellness or Medical Device? Here’s what the new FDA guidance says” now for free
In this webinar, you will learn how to apply the FDA’s updated General Wellness: Policy for Low Risk Devices guidance in practice – and how to assess claims, features, and UX consistently during ongoing development.
You’ll receive clear decision criteria and concrete examples to help determine whether a product remains a wellness product or falls within medical device regulatory scope.