FDA Releases Draft Guidance on Expanded Use of Remote Regulatory Assessments

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FDA releases draft guidance on expanded use of remote regulatory assessments

Today, the FDA released a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the agency generally intends the tool  to be incorporated consistently across all FDA-regulated products beyond the current COVID-19 public health emergency. Remote assessments of an FDA-regulated establishment and/or its records can help determine compliance with applicable FDA requirements, inform regulatory decisions and verify information submitted to the agency. They have also been a valuable tool in the nation’s response to the public health emergency, as the FDA fast-tracked their wider use to help get critical medical products to the front lines in the fight against the pandemic while keeping normal business operations moving. 

“The draft guidance, ‘Conducting Remote Regulatory Assessments Questions and Answers,’ is intended to provide transparency to stakeholders about how RRAs may be used and to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 The draft guidance covers voluntary and statutorily authorized RRAs but does not change the core requirements of inspections and pre- and post-market authorities.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,” said FDA Commissioner Robert M. Califf, M.D., and Associate Commissioner for Regulatory Affairs – Office of Regulatory Affairs Judith A. McMeekin in an FDA press release. “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.”

Using advanced tools such as RRAs can help improve the efficiency of FDA’s 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.  

Source: FDA press release