FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health
July 22, 2022
Dear International Colleague,
The following statement is attributed to FDA Commissioner Robert M. Califf, M.D., and Associate Commissioner for Regulatory Affairs Judith McMeekin, Pharm.D.
The U.S. Food and Drug Administration prioritizes the health and safety of American consumers and patients as well as animals and uses a variety of tools for the appropriate oversight of FDA-regulated products and establishments. With manufacturers and supply chains dispersed around the world, the FDA works to help ensure that only products that meet our rigorous standards reach the U.S. marketplace.
Similar to the industries we regulate, we continually seek ways to use advanced tools, including technology, to meet our regulatory mission and assess compliance with federal laws. Enhancing our oversight approaches helps us increase the speed of information that comes to the agency and improves the efficiency of how we operate, furthering our mission to protect the public health. As the world continues to move into the digital era, the integration of remote technologies with in-person activity provides a means for the interaction between the FDA and regulated industries to become more efficient so that the agency can have confidence in its assessments and the industry can implement innovations and quality systems in a more rapid and effective manner.
Today, the FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across all FDA-regulated products beyond the current COVID-19 public health emergency. These remote assessments of an FDA-regulated establishment and/or its records can help determine compliance with applicable FDA requirements, inform regulatory decisions and verify information submitted to the agency. They have also been a valuable tool in the nation’s response to the public health emergency, as we’ve fast-tracked their wider use to help get critical medical products to the front lines in the fight against the pandemic while keeping normal business operations moving.
Importantly, RRAs are an additional regulatory tool that does not replace inspections or other established means of obtaining information necessary for the FDA to accomplish its public health mission. Today’s draft guidance lays out how we intend to leverage this tool to advance our mission as we further incorporate modernized approaches to protecting public health.
Over the last two years, we’ve performed more than 1,470 domestic and more than 600 foreign entity establishment RRAs. As a result of these RRAs, we’ve identified unreported adverse events, gathered information to add products that appear to be violative to import alerts, evaluated the status of companies correcting issues from a previous inspection and helped the agency make regulatory decisions for product premarket submissions. RRAs are effective in getting essential information to regulators, enabling the FDA to intervene when needed and use agency resources more efficiently to do so.
The draft guidance, “Conducting Remote Regulatory Assessments Questions and Answers,” is intended to provide transparency to stakeholders about how RRAs may be used and to promote consistency in the way RRAs are conducted. The draft guidance covers voluntary and statutorily authorized RRAs but does not change the core requirements of inspections and pre- and post-market authorities. Except for RRAs for establishments required to comply with the Foreign Supplier Verification Programs (FSVP) regulation, an RRA does not function as an inspection.
We intend to continue to use RRAs, as appropriate, according to a risk-based approach that best protects public health. For example, when we are unable to deploy in-person staff due to travel restrictions, we may determine that a RRA is an appropriate tool. RRAs may also be used to efficiently assess establishments identified in product applications when these establishments have a prior history of compliance. Where appropriate, RRAs allow the FDA to review information such as livestreams and records provided by a company without going on-site, which can make better use of limited agency resources and give industry more scheduling flexibility.
As part of the FDA’s Fiscal Year 2023 budget request, the agency has requested additional authorities to expand the ability to use remote regulatory tools across all commodities. The agency currently relies on voluntary cooperation for the use of these tools for non-drug establishments or when the RRA does not involve assessing a food importer’s compliance with FSVP.
Using advanced tools like RRAs can help improve the efficiency of our work, strengthens the nation’s ability to respond to future public health emergencies and promotes consistent, data-driven and risk-based oversight for FDA-regulated products.
These modernization efforts will continue to help shape the way we perform our vital regulatory role as we optimize emerging tools and apply them consistently across FDA-regulated products. Implementing smarter technology and business processes like RRAs helps us advance our public health mission and provide the robust oversight needed to protect patients and consumers.
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