'Nsr device' presentation slideshows

506 views • 34 slides

Investigational Device Exemption (IDE) Overview for IRBs

Investigational Device Exemption (IDE) Overview for IRBs. Marian Serge, RN Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health FDA. Topics. Provision of IDE regulations Medical device definition When is an IDE not needed

639 views • 32 slides

Device Research

Device Research. Presented by Marian Serge, R.N. Goals. Identify devices Recognize difference between significant risk (SR) and non-significant risk (NSR) devices Explain how an Investigational Device Exemption (IDE) is obtained for SR and NSR devices Discuss IRB responsibilities

263 views • 26 slides