FDA Finalizes Guidance on Conducting Remote Regulatory Assessments

Lexology July 2, 2025
Hogan Lovells

The Food and Drug Administration (FDA) published its final guidance for industry entitled “Conducting Remote Regulatory Assessments – Questions and Answers” on June 26, 2025.¹ Initially published in draft format in July 2022² with a revised draft guidance published in January 2024,³ the final guidance formalizes FDA’s use of remote regulatory assessments (RRAs) for FDA-regulated products outside of public health emergencies such as the COVID-19 pandemic. As discussed in more detail below, RRAs are remote examinations of FDA-regulated establishments and/or their records to evaluate compliance with FDA requirements. The final guidance largely mirrors the January 2024 edition of the draft guidance. It is aimed at helping industry understand RRAs and making more effective use of RRAs in regulatory activities.

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