FHA bridges clinical relevance with regulatory rigor — guiding AI-enabled medical devices and digital health teams from software engineering to approval.
View our case studies40+
Years across pharma and device development
100+
Clinical trials designed and executed
CPT
Current voting member,
AMA CPT Editorial Panel
65+
FDA submissions supported
(clearances, Pre-Subs, BDD, TAP)
Clarify your FDA Total Product Life Cycle, clinical, and reimbursement route before you commit resources.
Design validation programs and submissions that comply with agency and payer requirements.
Align coding, coverage, and adoption strategy so cleared technology gets used.
Explore how FHA supports innovation
Six disciplines FHA brings to every engagement — from early concept through clearance and commercialization.
FDA Total Product Life Cycle strategy, pathway selection, Pre-Subs, PCCPs, and alignment with U.S., EU, and Health Canada expectations.
Learn More 02Refine concepts and align development with clinical relevance, regulatory pathway, and reimbursement.
Learn More 03MRMC and non-inferiority designs, data-quality plans, human factors, and validation programs.
Learn More 04Objective review of claims, evidence, study protocols, labeling, and technical architecture.
Learn More 05CPT strategy, payer dossiers, and navigation of commercial, Medicare, and MolDX policies.
Learn More 06Dataset strategy, training controls, evaluation metrics, drift monitoring, and integration.
Learn MoreThe FHA Vision
We bridge clinical relevance with regulatory rigor, guiding innovation from software engineering to approval. Founded by Dr. Frank and a cross-disciplinary team, FHA unites leaders in regulatory science, clinical research, and AI diagnostics.
Learn about FHAInsights
Perspectives from FHA on regulatory strategy, clinical evidence, and digital health policy.
FeaturedAI-enabled medical devices are routinely cleared by FDA, yet commercial adoption is often blocked by unclear reimbursement. CPT Appendix S provides the framework to align AI work with coding, valuation, and payer expectations.
FeaturedA year of rapid transformation, investor recalibration, and regulatory evolution — assessing where MedTech and AI-enabled Software as a Medical Device truly stand.
FeaturedFDA announced agency-wide deployment of agentic AI to support regulatory, scientific, and administrative workflows — with implications for developers of AI-enabled diagnostics.
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