USA – FDA describes plans to expand remote regulatory assessments

The US Food and Drug Administration (FDA) released draft guidance on Friday that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as it eases out of pandemic response mode. The guidance covers triggers for when FDA will request or require remote assessments and how these audits will be coordinated with onsite inspections.

These tools are not intended to replace onsite inspections but instead, the guidance “lays out how we intend to leverage this tool to advance our mission as we further incorporate modernized approaches to protecting public health” said FDA Commissioner Robert Califf and Judith McMeekin, associate commissioner for regulatory affairs.

FDA officials hinted at an earlier meeting that this hybrid inspection model incorporating both onsite and remote interactive evaluations would be here to stay in the post-pandemic world. (RELATED: FDA official: Virtual audits, records requests may be sticking around, Regulatory Focus,27 June 2022)

This guidance replaces FDA’s draft guidance issued at the height of the pandemic on its approach to remote inspections. (RELATED: FDA issues long-awaited pandemic remote inspections guidance, Regulatory Focus 14 April 2021)…