SOCRA CCRP Practice Exam

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Who reviews a Significant Risk device study first?

FDA
IRB
Sponsor/investigator
Department of Health

The correct answer is: FDA

The other options are incorrect because they are not responsible for reviewing Significant Risk device studies. B IRB, or Institutional Review Board, is responsible for reviewing studies that involve human participants to ensure ethical standards are met. C: Sponsor/investigator may be responsible for conducting the study, but not reviewing it. D: Department of Health may regulate medical devices but does not review studies. The FDA, or Food and Drug Administration, is the regulatory body responsible for reviewing and approving medical device studies, particularly those classified as Significant Risk.