FDA Plans to Continue Remote Regulatory Assessments
The U.S. Food and Drug Administration (FDA) recently released a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the agency intends to use the tool.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.