FDA Strategy

Bridge milestone · Series A catalyst

FDA 510(k) clearance

The single most important regulatory milestone for unlocking US commercial expansion. Bridge funds the pre-submission; Series A funds the rest.

~10×

US market vs EU

Regulatory pathway

2026

Pre-submission Q-Sub

🔄 In preparation

2026-27

510(k) submission

Planned

2027 (target)

510(k) clearance

Target

2027 (target)

First US commercial deployment

Planned post-clearance

Predicate device strategy

DermaSensor De Novo (DEN230008, January 2024)

Established a regulatory category for AI-based dermatology decision support devices intended for non-specialist use. This provides a viable 510(k) predicate pathway for similar devices.

Our regulatory strategy explores:

Path A · Sequential 510(k)

Start with a narrower indication aligned with DermaSensor's De Novo predicate, then expand via sequential 510(k) submissions to broader claims (severity measurement of multiple pathologies).

Path B · De Novo

If the indication for use diverges significantly (severity + multi-pathology), a De Novo classification may be required. Our advisor is evaluating both pathways.

Existing US presence

Johnson & Johnson

Multi-year contract, operating from US since 2022. Pre-dates FDA. Soft commercial validation in US clinical research.

ICON (top-5 CRO)

Contracted Q1 2026 · Almirall HS trial & Protagonist Therapeutics Psoriasis Phase 2.

Sagimet Biosciences

Alopecia Phase 3, via ICON.

US regulatory advisor

We work with a US-based regulatory consultant (name available upon request under NDA) to manage:

• Pre-submission Q-Sub preparation
• FDA correspondence and meetings
• 510(k) submission strategy and document preparation
• Post-clearance compliance planning

Investment use

The Bridge round allocates ~25% of funds (€375K-€500K) to FDA pre-submission completion. The Series A post-bridge allocates ~35% of funds to the rest of the FDA pathway (clinical evidence supplementation if required, QSR adaptation, Clinical Affairs & Evidence Manager (US), post-clearance commercial enablement):

Pre-submission preparation and FDA fees

Regulatory consulting fees (US-based)

Clinical evidence supplementation (if requested by FDA)

Quality system adaptation for FDA QSR (21 CFR 820)

First Clinical Affairs & Evidence Manager, US hire

Mitigation if FDA timeline slips

Not a survival requirement

FDA is a major catalyst but not a survival requirement. Legit.Health is currently generating revenue without FDA in 7 markets. If FDA timeline slips by 12-18 months, the business continues growing in EU + Brazil + UK markets. The investment use plan has contingencies to redirect funds to EU/UK expansion if needed.