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USFDA's Draft Guidance: Conducting Remote Regulatory Assessments Q&A

On 22-July 2022, USFDA released multiple guidance among them one is "Conducting Remote Regulatory Assessments Questions and Answers".


This guidance describes the Agency’s current thinking regarding its use of Remote Regulatory Assessments (RRAs) in order to increase the industry’s understanding of RRAs and facilitate the FDA’s process for conducting RRAs.


One set of tools used during the pandemic for oversight of FDA-regulated products has been remote regulatory assessments (RRAs). The types of RRAs are “remote interactive evaluations, and “remote record reviews.”

An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. RRAs assist in protecting human and animal health, informing regulatory decisions, and verifying certain information submitted to the Agency. RRAs are a tool FDA may use to support regulatory decisions and oversight activities.


FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs and help maximize compliance with FDA-regulated products. This draft guidance provides answers to frequently asked questions regarding what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.


The Agency believes that the FDA’s use of both voluntary and mandatory RRAs, as applicable, for all types of FDA-regulated products, is in the interest of public health, and the Agency is issuing this guidance to provide further transparency to stakeholders about the circumstances in which RRAs may be used both during and beyond the COVID-19 pandemic and promote greater consistency in the way RRAs are conducted.


CLICK this LINK to know conducting Remote Regulatory Assessments.



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