Decimal.regulatory
FDA Readiness:
Decimal Health evaluates companies’ readiness through a six step process to becoming a digital therapeutic.
![FDA Readiness FDA Readiness](https://decimal.health/hs-fs/hubfs/DecimalHealth_November2023/Images/FDA-readiness-icon.jpg?width=280&height=280&name=FDA-readiness-icon.jpg)
Decimal.health works with health systems, payers, digital health founders and funders, pharma and medical device firms to help them navigate the intricacies of the regulatory space.
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.
![FDA Approval Process FDA Approval Process](https://decimal.health/hs-fs/hubfs/DecimalHealth_November2023/Images/FDA-approval-process-icon.jpg?width=280&height=280&name=FDA-approval-process-icon.jpg)