LabelingSponsors of nonsignificant risk studies must label the device in accordance with 21 CFR 812.5.Under 21 CFR812.5 an investigational device or its immediate package must bear a label with thefollowing information: The name and place of business of the manufacturer, packer, or distributor The quantity of contents, if appropriate andThe statement, "CAUTION Investigational device. 8Key References.9Revision History:Version1: June 5, 2014Version2: September 3, 2015Version3: October 19, 2015Version4: December 11, 2015Version5: February 29, 2016Version6: October 20, 2017Version7: Augof 10 VCU/VCUHS NSR INE Sponsor-Investigator Responsibilities (V7: August 2020)Įvcuoffice otthtor Rese e Vice Presidenarcn andt\nno\JationSponsor Responsibilities for Non-Significant Risk Device StudiesSponsors of nonsignificant risk studies must comply with the abbreviated IDE requirements set forth in21 CFR 812.2(b). 6Investigator Responsibilities for Non-Significant Risk Device Studies.8A. 6 Other Reports Requested by a reviewing IRB or FDA. VcuOffice of the Vice Presidentfor Research and Innovation Significant Risk Device Determination. 5 of 10 VCU/VCUHS NSR INE Sponsor-Investigator Responsibilities (V7: August 2020) This document outlines Federal Regulationsregarding responsibilities of Sponsors and Investigators for an IDE.ContentsVCU/VCUHS NSR IDE Sponsor-Investigator Responsibilities.1Sponsor Responsibilities for Non-Significant Risk Device Studies.3A. The Sponsor and Investigator or Sponsor-Investigator (if the same individual),must understand and agree to abide by all responsibilities.
This means that such investigators have additionalresponsibilities.All VCU/VCUHS faculty/employees who hold an IDE must abide by all relevant federal, state andVCU/VCUHS policies. VcuOffice of the Vice Presidentfor Research and InnovationVCU/VCUHS NSR IDE Sponsor-Investigator ResponsibilitiesA sponsor-investigator assumes BOTH investigator and sponsor responsibilities as outlined in the FDACode of Federal Regulations 21 CFR 812.
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