Regulatory Background on Reclassification

First Page		Document Content
Technology Premarket approval Medical device Federal Food Drug and Cosmetic Act Humanitarian Device Exemption Clinical trial Investigational Device Exemption Center for Devices and Radiological Health Food and Drug Administration Medicine Health		Regulatory Background on Reclassification Add to Reading List Source URL: www.fda.gov Download Document from Source Website File Size: 49,74 KB Share Document on Facebook

	Stanford University HRPP Policy Guidance Humanitarian Use Device (HUD) DocID: 1rbpU - View Document
	The FDA Medical Device User Fee Program: MDUFA IV Reauthorization DocID: 1q9iz - View Document
	IMDRF Presentation - Jurisdictional update - US DocID: 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 SERVICES DocID: 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 to DocID: 19OOb - View Document