FDA Finalizes Guidance on Conducting Remote Regulatory Assessments

What are Remote Regulatory Assessments?

In response to the COVID-19 pandemic, FDA introduced RRAs as an oversight tool to facilitate FDA's regulatory activities when travel restrictions limited the agency's enforcement operations. The term “RRA” refers to remote examinations of FDA-regulated establishments and/or their records to evaluate compliance with FDA requirements (i.e., remote interactive evaluations and remote record reviews).⁴ RRAs can be mandatory or voluntary.⁵ For food products, FDA only has the authority to initiate a mandatory RRA when conducting a Foreign Supplier Verification Program (FSVP) inspection. Refusal to participate in a mandatory RRA can result in enforcement action, such as the refusal of food offered for import.

Under a voluntary RRA, FDA will request that an establishment consent to participating in the RRA, generally in writing. FDA will typically offer to discuss expectations for the proposed RRA before the establishment consents to participating. Once consent is given, FDA will request and review documents, meet virtually with establishment personnel, and in some cases request a video review of the facility, data, or other information. In the final guidance, FDA states it will not take enforcement action against an establishment “solely” based on its refusal to participate in a voluntary RRA.⁶ If an establishment refuses to participate in a voluntary RRA, FDA may consider whether additional activities are necessary to exercise its oversight responsibility, such as an inspection, based on considerations including when the establishment was last inspected, the agency's risk assessment, and other relevant factors. 

RRAs are not inspections and will not result in FDA Form 483 inspectional observations. However, at the close of the RRA, FDA may hold a closeout meeting with the establishment where FDA would present a written list of RRA observations. Establishments are encouraged to submit responses to RRA observations received at a closeout meeting within 15 business days. Finally, FDA intends to memorialize the RRA in a report consisting of a narrative and supporting documents that summarizes what was reviewed, what was found during the review, and any observations identified. RRA reports and observations are subject to public release under the Freedom of Information Act, with the standard disclosure protections.

Overview of Final Guidance

The final guidance is written in question and answer form and is largely consistent with the draft guidance published in January 2024, but with several clarifying revisions. Notable revisions include:

1. Mandatory v. Voluntary RRAs. The final guidance clarifies that when requesting an RRA, FDA intends to indicate whether it is a mandatory or voluntary RRA, and in the case of mandatory RRAs, the applicable legal authority.⁷
2. Procedure for Initiating a Voluntary RRA. FDA further refined its procedure for initiating a voluntary RRA, indicating that FDA will offer the establishment an opportunity to discuss the RRA and FDA's expectations in advance of the establishment consenting to the RRA.⁸
3. Confidentiality. FDA clarified that RRA reports and other records provided to FDA may be subject to public disclosure via Freedom of Information Act requests.⁹

Next Steps

Companies should review the final guidance to ensure they understand FDA's expectations in advance of the agency initiating a RRA. We are available to help advise companies with RRAs.

Authored by Maile Gradison, Anneke Altieri, and Erin Pannek.