Published on: 31/05/2024
FDA approval ensures safety and effectiveness—but CMS needs proof of clinical value. Here’s how to align your strategy with both mandates.
NovelFDACMSFood and Drug AdministrationCenters for Medicare & Medicaid ServicesTechnical OerformanceSafety ProfileBiocompatibilityClinical ValueEfficiencyFDA ClearanceEvidenceReimbursementClinical Benefit