U.S. FDA Publishes Final Guidance for Remote Regulatory Assessments

On June 26, 2025, the U.S. Food and Drug Administration (FDA) finalized its long-anticipated guidance, Conducting Remote Regulatory Assessments: Questions and Answers, which builds on draft guidance issued in July 2022 and again in January 2024.¹ The final guidance clarifies the FDA’s expectations, authority, and process for using remote regulatory assessments (RRAs) across FDA-regulated industries. It also reflects the agency’s commitment to modernizing oversight through increased use of digital tools.

This alert reviews the key developments, outlines what the final guidance means for industry, and highlights practical considerations for compliance.

A Brief History: RRAs From Pandemic Tool to Permanent Fixture

RRAs emerged during the Covid-19 public health emergency, when travel restrictions made inspections difficult. The agency used livestreams, document review, and virtual interviews to assess compliance. RRAs proved effective and scalable, prompting FDA to begin formalizing the approach through draft guidance in 2022 and 2024. Now, with the June 2025 guidance finalized, RRAs appear to be a permanent part of the FDA regulatory and compliance toolkit.

What the Final Guidance Says

The final guidance defines RRAs as remote examinations of an FDA-regulated establishment or its records to evaluate compliance with FDA requirements. Importantly, the guidance reaffirms that RRAs are not inspections under Section 704(a)(1) or 704(a)(5) of the Federal Food, Drug, and Cosmetic Act (FDCA), which require physical entry to a facility by FDA personnel. Instead, RRAs serve as a separate oversight mechanism that may precede or follow an inspection or stand alone in certain contexts.

The guidance draws a clear distinction between mandatory and voluntary RRAs. Mandatory RRAs are those conducted pursuant to the FDCA. These include records requests under FDCA Section 704(a)(4) for drug and device establishments² and under Section 805 for food importers subject to the Foreign Supplier Verification Program (FSVP). According to the Final Guidance, refusing to participate in a mandatory RRA³ is a violation of the FDCA that may lead to regulatory action by FDA.

In contrast, voluntary RRAs may be requested by FDA in any situation where it deems remote review appropriate. The Final Guidance clarifies that establishments may decline to participate in a voluntary RRA and that such a refusal does not constitute a violation of the FDCA. However, such a refusal may delay FDA’s ability to make regulatory decisions, including those tied to pending applications or risk-based inspection planning.

The guidance also emphasizes that RRAs are applicable across a broad range of FDA-regulated products, including human and animal drugs, biologics, medical devices, food, and tobacco.

Practical Mechanics of an RRA

An RRA typically begins with FDA contacting an establishment’s designated representative. The agency may review production records, electronic data, and other documentation and may also conduct virtual interviews or livestream walkthroughs. While RRAs do not result in a Form FDA 483, List of Inspectional Observations, FDA may issue a written list of RRA observations at the close of the assessment.

In the Final Guidance, FDA commits to preparing a narrative report at the conclusion of most RRAs. This document will summarize the scope of the review, the information collected, and any observations. These reports are often used to inform future inspections or enforcement. Importantly, such reports may be subject to public disclosure under the Freedom of Information Act, with appropriate redactions for confidential commercial or personal information.

Key Updates From the 2024 Draft

While building on the January 2024 draft, the final guidance reinforces and clarifies several important aspects of FDA’s approach. First, it standardizes FDA communication protocol, ensuring that establishments are informed at the outset whether an RRA is mandatory or voluntary and under what legal authority the request is made. It also expands FDA’s discretion to consolidate records requests under a single Form FDA 4003 when reviewing multiple applications during preapproval and pre-licensing inspections.

In addition, the final guidance clarifies the scope of FDA follow-up activities. RRAs may now be used more routinely to verify corrective actions following an inspection or to gather information needed for pending submissions. The guidance also confirms that while RRAs and inspections are not conducted simultaneously, information obtained during an RRA may be incorporated into the findings of a subsequent inspection.

Implications for Industry

FDA-regulated entities should expect RRAs to become increasingly common. The agency has made clear that RRAs will be used not only during emergencies but as a core oversight tool. As this shift continues, companies should ensure that their digital records are well organized, accessible, and inspection-ready — just like paper records during an onsite visit.

To begin, firms should look to integrate RRA preparedness into their broader quality management systems. Remote assessment readiness should become a standard element of quality assurance rather than an ad hoc response. This includes embedding procedural expectations for remote record sharing, virtual walkthroughs, and real-time communication protocols.

The increasing use of digital tools also elevates the importance of data integrity and cybersecurity. Companies should ensure that electronic records are accurate, secure, and retrievable in ways that withstand FDA scrutiny during remote interactions. This shift demands not only technical infrastructure but also governance practices.

Additionally, the growing role of RRAs requires investment in technology and training. Companies — especially those with global operations — should commit resources to enhance digital infrastructure and ensure that personnel across facilities understand the expectations and mechanics of participating in a remote assessment. Preparing teams will be essential to maintaining credibility and avoiding delays when the FDA initiates contact.

Compliance Tips: How to Prepare Now

• Identify a Designated Contact: Ensure that FDA registrations and applications list a current, responsive individual who can coordinate RRAs.
• Evaluate Technological Readiness: Confirm the facility’s ability to support high-quality livestreaming, secure file sharing, and real-time communication.
• Develop or Update Standard Operating Procedures: Document internal procedures for handling both voluntary and mandatory RRAs, including timelines and escalation paths.
• Train Key Personnel: Educate team members on expectations during a remote assessment and practice simulated virtual interactions.
• Keep Records RRA-Ready: Maintain up-to-date, well-organized records that can be easily shared with FDA upon request.
• Understand Your Obligations: Clarify when participation is mandatory, and carefully review the consequences of refusal for voluntary RRAs.

By formalizing remote assessments, the agency has expanded its reach while maintaining flexibility. For industry, the message is clear: Be prepared for oversight, whether in-person or online.

Sidley’s team of FDA lawyers and regulatory compliance experts are available to assist your team with developing your RRA response strategy.

¹ Sidley’s update on FDA’s January 2024 draft guidance can be found here.

² Under Section 704(a)(5)(C) of the FDCA, sites may also include sites, entities, or facilities subject to bioresearch monitoring inspections.

³ The FDA 2025 RRA guidance states: “As used in this guidance, references to a ‘mandatory RRA’ mean RRAs for which an establishment’s participation is required by legal authorities.”