Travel restrictions, brought on during the COVID-19 pandemic, forced the US Food and Drug Administration (FDA) to adapt its mode of operations with respect to field inspections by employing a remote regulatory assessments (RRA) strategy. FDA used these RRAs to ensure continuity of inspections for compliance with applicable FDA requirements where an on-site presence was not possible. From the experiences gained from RRAs, the FDA acknowledges their usefulness in situations that fall outside of circumstances such as those in a pandemic and find it beneficial for all types of FDA-regulated products.
RRAs can be either voluntary or mandatory but are not meant to be used to replace or limit inspections. Instead, they are used as a means to follow-up on activities such as complaints or to provide additional information pertaining to a corrective action that has been implemented. While the FDA may initiate an RRA, it should be noted that they are not able to accept manufacturer’s requests for an RRA.
In a recently revised Q&A guidance document published in January 2024, the FDA goes into detail about the scope of RRAs and how they are conducted. Most notably, the Q&A includes written response times for observations, FDA reporting criteria, and documentation to support the assessment.
The comment period on the revised draft guidance closes on 26 March 2024. Comments can be submitted to regulations.gov with the docket number FDA-2022-D-0810.
Find the link to the FDA page with access to both the Q&A and comment submission here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/conducting-remote-regulatory-assessments-questions-and-answers
