FDA Issues Final Guidance Addressing Remote Regulatory Assessments

On June 26, 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a final guidance that describes the Agency’s conduct and use of remote regulatory assessments (RRAs).¹ RRAs refer to a category of oversight tools used by the Agency to remotely assess any FDA-regulated establishment and/or its records for compliance with applicable FDA requirements.² They may also be used to help support the timely review of a marketing submission.³ When RRAs are conducted under FDA’s various statutory or regulatory authorities, establishments must participate in the remote assessment. When RRAs are not, establishments may voluntarily participate but are not required to.⁴

This “Conducting Remote Regulatory Assessments—Questions and Answers” final guidance clarifies and replaces the preceding draft guidances (issued in 2022 and 2024)⁵ in five ways:

1. Distinguishing more clearly between mandatory and voluntary RRA requests

2. Clarifying how FDA intends to inform establishments of the terms of participation in voluntary RRAs and obtain their consent to conduct the RRA

3. Clarifying mechanisms for electronic records reviews and conditions under which live data access might occur

4. Addressing concerns about confidentiality and security of establishment information reviewed by FDA

5. In general, facilitating transparency and consistency in FDA’s use of RRAs across regulatory products, as applicable⁶

This Advisory summarizes the notable changes from the revised draft guidance. For a deeper dive into RRAs, we encourage you to read our previous Advisory.⁷ Establishments should not assume that FDA’s use of RRAs, or the issuance of this final guidance itself, signals a shift away from FDA inspections. FDA explicitly states that an RRA is not an inspection. An RRA can precede, prompt, or be a follow-up to an inspection. An RRA may also be conducted (e.g., via livestreaming) during oversight activities that are independently conducted by state or foreign regulatory partners.⁸ The Agency will continue to perform inspections as necessary.⁹ Indeed, FDA recently announced that it plans to expand the use of unannounced inspections of foreign manufacturing facilities and to increase its inspection presence abroad.¹⁰

Distinguishing Between Mandatory and Voluntary RRAs; Notice and Participation in RRAs. The Agency will specify whether the RRA is mandatory or voluntary when it issues an RRA request to an establishment (e.g., a drug or device manufacturer, or a site or facility subject to bioresearch monitoring inspections).¹¹

As part of a voluntary RRA request, the Agency will typically offer the establishment an opportunity to discuss the RRA to inform the establishment’s decision on whether to consent to it.¹² FDA underscores the voluntary nature of such requests. FDA does not intend to take enforcement action against an establishment solely on the grounds that the establishment declines to participate in a voluntary RRA.¹³ However, upon agreeing to participate in a voluntary RRA, FDA expects the establishment to provide the requested records and other information within a reasonable amount of time or otherwise communicate the establishment’s need for an extension as soon as possible.¹⁴

By comparison, FDA may take enforcement action against establishments that decline to participate in a mandatory RRA issued in accordance with the Federal Food, Drug, and Cosmetic Act and FDA regulations.¹⁵ The contact listed in an establishment’s registration should be aware that they may become the point of contact for a mandatory RRA request.¹⁶

FDA may issue a mandatory RRA in advance of pre-approval and pre-licensing inspections for records that relate to products named in multiple applications. In such instances, FDA intends to issue one Form FDA 4003 to the establishment that covers the request for records or other information for the relevant products in the applications being assessed.¹⁷

Electronic Record Reviews. FDA may request to review electronic systems and source records via livestream, video, or screen sharing. FDA generally does not intend to record these sessions, but will inform the establishment if it decides to record.¹⁸

Electronic Transmission of Records. FDA generally expects establishments to submit requested records and information electronically. FDA intends to identify and use a secure means to facilitate the transmission and comply with federal laws and regulations governing confidentiality and retention.¹⁹

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We will continue to monitor FDA developments relating to RRAs and FDA establishment inspections, including inspections of foreign facilities. If you have any questions or would like more information, please reach out to one of the authors of this Advisory or your existing Arnold & Porter contacts.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.