CBER Document Control Center / Rockville Pike / / /
IndustryTerm
manufacturing defect / manufacturing / /
MedicalCondition
disease / rare disease / /
Organization
CBER Document Control Center / U.S. Department of Health and Human Services / office of Communication / Outreach and Development / Institutional Review Board / Food and Drug Administration / Center for Devices and Radiological Health / Division of Dockets Management / Food and Drug Administration Center for Devices / Radiological Health / Device Evaluation Program Operations Staff Center for Biological Evaluation and Research Contains Nonbinding Recommendations / FDA’s HUD / FDA’s office of Orphan Products Development / Radiological Heath Document Mail Center / office of Orphan Products Development / Radiological Health office of Device Evaluation Program Operations / Center for Biologics Evaluation and Research / Center for Biologics Evaluation and Research Food and Drug Administration / /
Draft Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff