The draft guidance, "Conducting Remote Regulatory Assessments Questions and Answers," is intended to provide transparency to stakeholders about how RRAs may be used and to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 The draft guidance covers voluntary and statutorily authorized RRAs but does not change the core requirements of inspections and pre- and post-market authorities.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.


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


SOURCE U.S. Food and Drug Administration

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