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USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers

Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the industry titled Conducting Remote Regulatory Assessments Questions and Answers to describe the Agency’s current thinking regarding its use of remote regulatory assessments (RRAs) to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs.

Remote Regulatory Assessment (RRA) is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. RRAs are a tool FDA may use to support regulatory decisions and oversight activities.

Among the tools are remote records requests, livestreaming video of operations, teleconferences, and screen sharing. These approaches enabled the agency to provide oversight to as many facilities as possible when travel was restricted while continuing to deploy our resources to protect patients and consumers and promote public health.

An RRA is different from an inspection under sections 704(a)(1) or 704(a)(5) of the FD&C Act. Typically, an inspection, as outlined in section 704(a)(1) of the FD&C Act, entails FDA-designated personnel physically entering (at reasonable times and in a reasonable manner) establishments regulated under the FD&C Act to assess compliance with relevant requirements.

As part of FDA oversight of FDA-regulated products and establishments, the Agency uses a variety of tools. During the COVID-19 pandemic, the FDA used RRAs to help the Agency conduct oversight, mitigate risk, and meet critical public health needs regarding certain FDA-regulated products, and these RRAs include:

  1. Mandatory RRAs involving review of records or other information submitted by certain establishments upon request from FDA and

  2. Voluntary RRAs involving remote requests for records and/or interactive evaluations (such as remote livestreaming video of operations, teleconferences, and screen sharing).

To know more about Remote Regulatory Assessment Expectations click this LINK and to review this draft guidance and submit comments, please visit the Federal Register website by March 26, 2024.  


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