Remote Regulatory Assessments Q&A: Here To Stay

By Emily Purchase, Quality, Regulatory and Compliance

The Food and Drug Administration (FDA) has issued updated guidance on Remote Regulatory Assessments (RRAs), which are examinations conducted remotely to assess compliance with FDA requirements. The updated guidance aims to clarify the benefits of RRAs, the consequences of non-compliance, and the relationship between RRAs and inspections or other regulatory partners. RRAs can be either mandatory or voluntary and are conducted to ensure compliance with FDA requirements without the need for on-site visits. The FDA has found RRAs to be effective in promoting compliance and addressing public health needs. During the COVID-19 pandemic, RRAs were especially useful in overseeing and mitigating risks associated with FDA-regulated products. The updated guidance provides valuable insight into frequently asked questions about RRAs and aims to ensure consistency in conducting these assessments. It emphasizes that RRAs are in the public health interest and reduce the burden of on-site assessments. The FDA believes that using both mandatory and voluntary RRAs is crucial for protecting the health and safety of citizens. Overall, the FDA's updated guidance on RRAs demonstrates its commitment to promoting compliance and ensuring the health and safety of the public.