§ 56.105 Waiver of IRB requirement

On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements contained in these regulations, including the requirements for IRB review, for specific research activities or for classes of research activities, otherwise covered by these regulations.

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FDA guidance that cites § 56.105

• Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers 15 Apr 2026
• Institutional Review Boards Frequently Asked Questions: Guidance for Institutional Review Boards and Clinical Investigators 5 Feb 2025
• Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products: Guidance for IRBs and Clinical Investigators 11 Sept 2023
• Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food and Drug Administration Staff 21 Apr 2022
• Acceptance Review for De Novo Classification Requests: Guidance for Industry and Food and Drug Administration Staff 5 Oct 2021
• Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1) draft 19 May 2021
• Individual Patient Expanded Access Applications: Form FDA 3926 3 Oct 2017
• Waiver of IRB Requirements for Drug and Biological Product Studies: Guidance For Sponsors, Clinical Investigators, and IRBs 3 Oct 2017
• Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation: Guidance for Industry 31 Jul 2015
• Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs 4 Jun 2010

Amendment history

Federal Register documents that created or amended this section.

• 46 FR 8975 27 Jan 1981