The Regulatory Pathway Brief
One written Regulatory Pathway Brief for one agreed US FDA question. We develop our own assessment from agreed device facts, without seeing your existing strategy. It covers four areas.
What’s included
- 01
Regulatory pathway
Likely classification and premarket route, with the basis and its limitations.
- 02
Predicate assessment
Potential predicate devices from public records where relevant, and the limits of their comparability.
- 03
Evidence requirements
Evidence gaps that could affect your testing or submission planning.
- 04
Recommendations and next steps
Written recommendations, the assumptions they rest on and the questions that still need formal confirmation.
An evidence decision, illustrated
In its 2024 review of Stelo, FDA described shared sensing hardware with the G7 predicate, previous testing that remained applicable, and Stelo-specific studies. Human-factors work examined whether buyers could recognise whether the product was appropriate for them and use it safely. These are selected parts of a wider assessment within Dexcom’s own product family.
A public FDA example, not a Falcr engagement.
PUBLIC FDA EXAMPLE · DEXCOM · 2024
Same sensor hardware. Different evidence.
G7
Prescription
Stelo
Over the counter
Existing Dexcom testing applied
- Biocompatibility
- Sterilisation
Stelo‑specific testing
- Buyer self‑selection
- Safe use of the system
Which differences need evidence before you commit to testing?
A public FDA example, not a Falcr engagement.
Selected evidence: FDA K234070, pp. 3, 6, 19–20 (PDF, opens in a new tab).