The U.S. Food and Drug Administration (FDA) recently released a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the agency intends to use the tool. RRAs were established during the COVID-19 pandemic to allow the agency to continue its regulatory oversight of industry, remotely. RRAs include, but are not limited to, activities such as remote evaluations and remote record reviews. The purpose of RRAs is not to replace inspections or other crucial, in-person duties; rather, RRAs are meant to supplement existing processes to achieve the agency’s public health goals efficiently.
FDA states that it has performed more than 1,470 domestic and 600 foreign entity establishment RRAs in the past two years. The RRAs have resulted in the identification of unreported, adverse events; the gathering of information necessary to add noncompliant products to the agency’s list of import alerts; the evaluation of companies’ statuses in correcting issues that were identified in prior inspections; and making informed regulatory decisions for product premarket submissions. FDA believes that RRAs are effective in delivering essential information to regulators, enabling the agency to intervene when needed, and enabling the efficient allocation of agency resources.
The draft guidance aims to provide transparency to stakeholders about how RRAs may be used and to promote consistency in the way RRAs are conducted. The 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.
FDA intends to use RRAs with discretion, grounded in a risk-based approach. For example, FDA may employ RRAs when the agency is unable to deploy in-person staff due to travel restrictions, or to efficiently assess establishments identified in product applications when the establishments have a prior history of compliance. Where appropriate, RRAs allow FDA to review information such as livestreams and records provided by a company without going onsite, which can make better use of limited agency resources and give industry more scheduling flexibility.
As part of 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 such tools for non-drug establishments or when the RRA does not involve assessing a food importer’s compliance with FSVP.
