FDA Update on IRB Written Procedures

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have published an update to the Guidelines for Institutional Review Board (IRB) Written Procedures. This guidance aims to harmonise regulatory requirements for the protection of human subjects in clinical investigations, as provided for in the 21st Century Cures Act.

Key Changes and Objectives

This update is intended for institutions and IRBs responsible for overseeing research involving human subjects, establishing clear written procedures to ensure:

• Protection of participants' rights and welfare.

• Regulatory compliance with HHS and FDA requirements.

• Transparency and consistency in ethical review and IRB operations.

The update includes a Written Procedures Checklist, which assists institutions in creating comprehensive and detailed policies, promoting harmonised practices and reducing regulatory burdens.

Impact on the Medical Device Industry

The changes aim to simplify regulatory compliance and ensure high ethical standards in the conduct of clinical trials. Medical device manufacturers should review and update their internal procedures to ensure ongoing compliance with the new guidelines.

For more information, please refer to the full document below.