Medical Devices Regulatory Affairs - MDRA Overview of Regulatory Requirements : Medical Devices FDA / CDRH Functioning Medical Device Classification Devices / Device Panels / Regulation Product Codes 21 CFR Parts 800-1299 Product Classification Database : 21 CFR Parts 862-892 Distinct Product Code Identification Procedure Total Product Life Cycle (TPCL) / TPCL Product Code Report General controls and Special controls Pre-market approval – PMA Adulteration Misbranding Electronic Establishment Registration Pre-market notification submission 510(k) 510(k) Marketing clearance process Medical Device Exemptions 510(k) FDA Clearance Medical Device Reporting – MDR Special labeling Establishment Registration and Medical Device Listing Reserve Devices Special 510(k) Abbreviated 510(k) Substantial equivalence Medical device labeling Post-market studies Medical device tracking Comparative Study : Medical Device Regulations in USA Medical Device Regulations in European Union Medical Device Regulations in India