FDA Publishes Revised Draft Guidance on Remote Regulatory Assessments
January 26, 2024
Dear International Colleague,
Today, the U.S. Food and Drug Administration published a revised draft guidance for industry titled Conducting Remote Regulatory Assessments Questions and Answers.
The FDA uses a robust, risk-based oversight approach to ensure the continued safety of the nation’s food and medical product supply. A 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. Some of the tools include remote records requests, remote livestreaming video of operations, teleconferences, and screen-sharing. These approaches have enabled the agency to provide oversight to as many facilities as possible when travel was restricted while continuing to deploy resources where possible to protect consumers and patients and promote public health.
For example, throughout the pandemic, the FDA used RRAs, domestically and abroad, for certain FDA-regulated products to help the agency conduct oversight, mitigate risk, and meet critical public health needs when inspections could not be conducted. Due to the success of these tools, the agency will continue to use RRAs, as appropriate, in overseeing regulated industry and ensuring the safety and effectiveness of all types of regulated products, supplementing critical oversight tools such as inspections.
The draft guidance, once finalized, will describe how the FDA will use RRAs for FDA-regulated products. The revised draft guidance reflects the agency's consideration of comments to the July 2022 draft guidance, as well as revisions to align with recent changes in law concerning mandatory records requests. The FDA welcomes public comments during the 60-day comment period.
To review the draft guidance and submit comments, please visit the Federal Register website by March 26, 2024.
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