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106. FDA Exempt Categories (§56.104-105)

FDA regulations exempt the following categories of clinical investigations from the requirements for IRB review:

  • Investigations that began before 7/27/81 if either of the following two conditions apply:

1.      The investigations were subject to IRB review requirements under FDA regulations prior to that date, and remain subject to review of an IRB that meets the FDA requirements in effect before 7/27/81.

2.      The investigations were not otherwise subject to IRB review requirements under FDA regulations before 7/27/81.

  • Emergency use of a test article if the emergency use is reported to the University Biomedical IRB within 5 working days (for use and reporting requirements, see the IRB policy for FDA exceptions to informed consent requirements and emergency use of test articles).

NOTE: Generally, subsequent uses of the test article at the institution require IRB review.

  • Taste and food quality evaluations and consumer acceptance studies may be exempt as follows:

o   If wholesome foods without additives are consumed.

o   A food is consumed that contains a food ingredient at or below the level and for a use found to be safe; or contains an agricultural, chemical, or environmental contaminant at or below the level found to be safe by the FDA, or approved by the EPA or the Food Safety and Inspection Service of the USDA. NOTE: Requires submission as exempt research, Category 6.

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