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Compliance In Focus
Posted by John Lehmann on Tue, Jan 5, 2016

Significant Risk vs. Non-Significant Risk Determination

Dr. Harvey Arbit of Arbit Consulting has penned a whitepaper for IMARC Research titled, “Significant Risk_Determination-1Risk/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).

Using algorithms, decision trees, or other tools can make this decision process simpler. Dr. Arbit provides us with 6 algorithms to consider:

  1. Categorization:  It deals with the overall categorization of the investigational article.
  2. IDE Status: After determining that the article is a medical device there are additional questions to be addressed. 
  3. Risk Assessment:  It is at this point the algorithm turns to the important question of SR or NSR.
  4. Protocol Consideration: The study itself needs to be considered when assessing risk.
  5. IVD Considerations (if applicable): If the device is an IVD there is another series of questions to be answered.
  6. MRI Considerations (if applicable): MRI is a category of medical devices that has its own complex algorithm, and requires a number of questions be addressed.

It is important to keep in mind that risk determination is a task shared by sponsors, sponsor-investigators, IRBs, and the FDA, with the ultimate goal being to identify the appropriate level of risk so that appropriate safeguards can be put into place to protect patients.

Please take time to read this informative whitepaper and share your comments with Dr. Arbit or with us!

Significant Risk/Non-Significant Risk Determination


photo credit: Playing 'Risk' via photopin (license)

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


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