FDA Guidance for Industry
From the Guidance introduction and background: An RRA (Remote Regulatory Assessment) is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. FDA uses a variety of tools5 for oversight of FDA-regulated products and establishments. During the COVID-19 pandemic, FDA used RRAs to help the Agency conduct oversight, mitigate risk, and meet critical public health needs with respect to certain FDA-regulated products. Based on these experiences, FDA has determined that RRAs are valuable oversight tools and, therefore, under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements.
FDA has developed this guidance to provide answers to frequently asked questions related to RRAs. This guidance is intended to help enhance industry’s understanding of RRAs, thereby facilitating FDA’s process for conducting RRAs. The guidance finalizes the revised draft guidance of the same title issued on January 26, 2024
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