FDA Readiness:
Decimal Health evaluates companies’ readiness through a six step process to becoming a digital therapeutic.
FDA Approval Process:
These components include assessing the product design, business model, regulatory pathway and requirements needed to obtain FDA approval or clearance, evidence generation with clinical trials and real-world evidence generation to prove intervention’s efficacy, reimbursement (including coverage, coding and pricing) and finally distribution workflows to distribute through prescribing channel.
