The wellness line
The wellness line: the Jan 2026 FDA guidances and where claims flip a wearable into a device.
Free field guide · PDF
Wearable & RPM Regulation2026 Field Guide
The wellness line, the reimbursement math, and the EU stack — with the connected-health work you need.
- RPM 2032
- $4.7B
- New CPT codes
- 2
- FDA guidances
- Jan 2026
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The reimbursement math
The reimbursement math: new 2026 CPT codes, the 2.5% factor increase, and the ACCESS model.
The EU stack
The EU stack: MDR Class IIa/IIb, §524B cybersecurity, and the AI Act for high-risk algorithms.
Sources & scope
- meddeviceguide.com, RPM Device Regulatory Pathway: FDA, CMS Reimbursement & EU MDR (2026).
- mindbowser.com, FDA Requirements for RPM Software Devices in 2026.
- LinkedIn, Is it a medical device or a wellness gadget? (2026).
This guide is market-access intelligence, not regulatory or legal advice. FDA guidance, CMS policy, and EU requirements change — professional review is required before business use.
Market Access Strategy Session
Wearable or RPM on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your connected-health route — wellness-vs-device strategy, CMS reimbursement math, and the EU regulatory stack.
Professional review is required before business use.
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