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Posted by John Lehmann on Tue, Jan 10, 2017

Comparing Significant Risk vs. Non-Significant Risk Studies

What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)?

Topics: Signficant Risk, Non-Signficant Risk

Posted by John Lehmann on Fri, Apr 08, 2016

Significant Risk vs. Non-Significant Risk Determination

Dr. Harvey Arbit of Arbit Consulting has penned a whitepaper for IMARC Research titled, “Significant Risk/Non-Significant Risk Determination and IDE Applicability.”  Although the Medical Device Amendments were enacted on May 28, 1976, it still seems that after all these years there is confusion and misunderstanding regarding the process for determining if an investigational device is Significant Risk (SR) or Non-Significant Risk (NSR).

Topics: Dr. Harvey Arbit, Signficant Risk, Non-Signficant Risk, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

Significant Risk/Non-Significant Risk Determination Whitepaper

Dr. Harvey Arbit of Arbit Consulting has penned a whitepaper for IMARC Research titled, “Significant Risk/Non-Significant Risk Determination and IDE Applicability.”  Although the Medical Device Amendments were enacted on May 28, 1976, it still seems that after all these years there is confusion and misunderstanding regarding the process for determining if an investigational device is Significant Risk (SR) or Non-Significant Risk (NSR).

Topics: Dr. Harvey Arbit, Signficant Risk, Non-Signficant Risk, IMARC Research Whitepaper

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