What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)?
Topics: Signficant Risk, Non-Signficant Risk
You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
What is the difference between Significant Risk studies (SR) and Non-significant Risk studies (NSR)?
Topics: Signficant Risk, Non-Signficant Risk
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
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