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![]() Pharmaceutical industry Health Pharmaceutical sciences Pharmacology Investigational Device Exemption Medical statistics Center for Devices and Radiological Health Humanitarian Device Exemption Premarket approval Food and Drug Administration Medicine Clinical research | Add to Reading List |
![]() | Stanford University HRPP Policy Guidance Humanitarian Use Device (HUD)DocID: 1rbpU - View Document |
![]() | The FDA Medical Device User Fee Program: MDUFA IV ReauthorizationDocID: 1q9iz - View Document |
![]() | IMDRF Presentation - Jurisdictional update - USDocID: 1pZXf - View Document |
![]() | This document is scheduled to be published in the Federal Register onand available online at http://federalregister.gov/a, and on FDsys.govP DEPARTMENT OF HEALTH AND HUMAN SERVICESDocID: 19Qhg - View Document |
![]() | Fact Sheet: 50cc SynCardia Total Artificial Heart Background The 50cc SynCardia Total Artificial Heart is a smaller version of the 70cc SynCardia temporary Total Artificial Heart that received FDA approval as a bridge toDocID: 19OOb - View Document |