FDA vs. CMS Mandates for Evaluating Novel MedTech

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
FDA vs. CMS Mandates for Evaluating Novel MedTech