[Answer] Who makes the initial risk determination for devices?

Answer: the sponsor-investigator

Most relevant text from all around the web:

Who makes the initial risk determination for devices? Who is responsible for making the initial risk determination for a device being used in a study? The sponsor-investigator . An investigator conducting a study of a medical device under an IDE is required to complete and sign Significant Risk and Nonsignificant Risk Medical Device Studies Guidance For IRBs Clinical Investigators and Sponsors January 2006 Tue Oct 31 2017 · The study’s sponsor is responsible for proposing the initial risk determination . The sponsor will submit this proposal to the IRB for consideration. FDA is also available to help make the determination and in some cases it’s possible that FDA has already made the risk determination before the study reaches the IRB—in these cases the FDA’s determination is final. For Significant Risk device studies the sponsor must submit an IDE application to FDA and receive approval and the device’s IDE number should be documented in your IRB application. Unless FDA has already made a risk determination for the device study the IRB is … Determination means settling of a question or (judicial) case by an authoritative decision or pronouncement . Determination means ascertaining or fixing of the quantity quality position or ... The sponsor-investigator makes the initial risk determination for the proposed study and presents it to the IRB . The IRB then reviews the sponsor-investigator’s risk determination and agrees or disagree...

Disclaimer: 

Our tool is still learning and trying its best to find the correct answer to your question. Now its your turn, "The more we share The more we have". Comment any other details to improve the description, we will update answer while you visit us next time...Kindly check our comments section, Sometimes our tool may wrong but not our users.

Are We Wrong To Think We're Right? Then Give Right Answer Below As Comment