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Posted by John Lehmann on Wed, Mar 04, 2015

Significant Risk vs. Non-Significant Risk – What’s the Difference?

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

Topics: Medical Devices, Significant Risk, Non-Significant Risk, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

Significant Risk vs. Non-Significant Risk – What’s the Difference?

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

Topics: Significant Risk, Non-Significant Risk, FDA

Posted by Brandy Chittester on Wed, Mar 04, 2015

Significant Risk/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, Significant Risk, Non-Significant Risk, Investigation Device

Posted by Brandy Chittester on Wed, Mar 04, 2015

Significant Risk vs. Non-Significant Risk – What’s the Difference?

What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)? Who makes the decision, why do they make the decision and how can it effect a clinical trial? Based on the FDA’s guidance for medical device studies and the Regulations, a SR device:

Topics: Significant Risk, Non-Significant Risk, 21 CFR 812, FDA

Posted by John Lehmann on Mon, Nov 06, 2017

Significant Risk/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, Significant Risk, Non-Significant Risk, IMARC Research Whitepaper

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