Expanding Use of Remote Regulatory Assessments: Guide

FDA has released a draft guidance on the expanded use of remote regulatory assessments (RRAs) beyond the Covid-19 pandemic to assess an FDA-regulated establishment and its records to determine compliance in lieu of conducting a physical inspection. The agency notes that RRAs will be an additional regulatory tool that does not replace inspections or other established means of obtaining information necessary for it to accomplish its public health mission.

FDA says that during the during the past two years, it “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The draft guidance, “Conducting Remote Regulatory Assessments Questions and Answers,” is intended to provide transparency about how such assessments may be used and to promote consistency in the way they are conducted. “We intend to continue to use RRAs, as appropriate, according to a risk-based approach that best protects public health,” the agency says. “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.”

The guidance says that examples of records or other information the agency may request during a remote assessment can include:

• Records of specific production lots or batches as well as product-specific information, such as periodic product reviews, product quality reports, equipment records, process validation records and reports, test results, product complaints or other information related to GMP compliance.
• Certain summaries or lists of records, such as a summary of batches manufactured and their disposition, or a summary of discrepancies and investigations related to manufacturing and testing.
• Read-only access to electronic databases, or a request that an establishment walk the agency through information in their database or provide data queries or summary data generated by the establishment from their databases.
• SOPs and records generated by the establishment to document control of quality systems or demonstrate compliance with applicable FDA requirements.
• Records or data related to the reporting or conduct of FDA-regulated research.

Additionally, FDA notes that it currently relies on voluntary compliance regarding remote assessments for non-drug establishments, but the fiscal year 2023 budget request seeks additional authorities to expand the regulatory tools’ use across all product categories.