DOCUMENT 10 · AUGUST 2026
Product Positioning & Regulatory Pathway
Whether Project Resonance begins as a wellness product, research platform, or regulated medical device — and the phased plan that keeps those options honest.
The three possible positions
| Position | What it permits | Key limitation | Recommendation |
|---|---|---|---|
| General wellness | Lifestyle-oriented use for relaxation, general well-being, recovery routines, or other carefully reviewed non-disease purposes. | Claims and risk profile must remain within FDA general-wellness policy; "low risk" cannot be assumed merely from the label. | Possible later launch position, only after engineering and counsel review. |
| Research platform | Controlled engineering, laboratory, and appropriately reviewed human-subject research to characterize field output, safety, and measurable outcomes. | An investigational product cannot be commercially promoted as proven therapy; human studies may require IRB review and IDE analysis. | Best initial development position. |
| Medical device | Disease- or condition-related indications supported by an identified classification and FDA marketing pathway. | Requires regulatory strategy, quality controls, evidence, and potentially 510(k), De Novo, or PMA review before marketing. | Potential long-term pathway after evidence and FDA feedback. |
Why research-first is the credible start
- The product is still being defined. Field strength, waveform, frequency range, exposure geometry, duty cycle, controls, and safety architecture must be verified before claims are selected.
- Intended use controls classification. FDA evaluates what a product is intended to do; marketing language, labeling, demonstrations, and sales training all matter.
- Evidence should precede therapeutic claims. Bench characterization, safety work, human-factors evaluation, and designed studies create the basis for a defensible later pathway.
- Investor credibility improves with staged decisions. A research-first plan separates engineering feasibility from clinical hypotheses, reduces unsupported-claim risk, and creates measurable go/no-go milestones.
Phased development and decision plan
| Phase | Objective | Required outputs | Decision gate |
|---|---|---|---|
| 1 · Define | Lock the intended-use options and technical requirements. | Claims inventory; user populations; engineering specification; preliminary hazard analysis; regulatory classification memo. | Approve one development position; prohibit all unapproved claims. |
| 2 · Characterize | Build alpha units and measure what the system actually produces. | Calibrated field maps; waveform/frequency verification; thermal, electrical, EMC pre-compliance; software controls; risk register. | Demonstrate repeatable output within documented safety limits. |
| 3 · Study | Generate credible safety and performance evidence. | Protocols; independent review; IRB/IDE determination where applicable; adverse-event process; statistical plan; study report. | Evidence supports wellness launch, medical pathway, redesign, or stop. |
| 4A · Wellness | Launch only with a low-risk, non-disease intended use. | Final labeling; claims substantiation; user instructions; training; complaint handling; counsel sign-off. | Commercial release remains inside the approved claims boundary. |
| 4B · Medical device | Pursue a defined disease/condition indication. | FDA Q-Submission; classification/predicate analysis; quality system; verification/validation; clinical evidence; marketing submission. | No medical promotion before applicable FDA authorization. |
Governance controls
Single claims owner
Regulatory counsel approves every website statement, deck, brochure, demo script, and distributor claim.
Separate research from sales
Research devices, records, and communications are clearly identified and managed under the applicable protocol and institutional requirements.
Design for the strict pathway
Maintain requirements, risk management, configuration control, verification records, cybersecurity documentation, and complaint processes from the beginning.
Escalate before changing intended use
New disease claims, treatment settings, patient populations, or autonomous software recommendations trigger a new regulatory assessment.
Investor-facing position
Project Resonance is a programmable electromagnetic research and wellness-platform concept in staged development. The initial program will establish engineering feasibility, exposure control, and safety evidence. Commercial claims and the final regulatory pathway will be selected only after independent testing and regulatory review. A future medical indication remains an option, not a present claim.
Current FDA basis: "General Wellness: Policy for Low Risk Devices," final guidance, January 6, 2026 · "How to Determine if Your Product is a Medical Device" · "Investigational Device Exemption (IDE)" · "IDE Approval Process." This document is a planning recommendation — not legal advice, an FDA determination, or proof that the present design qualifies as a general-wellness product. Obtain written advice from qualified medical-device regulatory counsel before testing on people, marketing, fundraising claims, or commercial distribution.