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draft guidance.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
Footnotes
1 90 Fed. Reg. 27319, 27319 (June 26, 2025); U.S. Food & Drug Admin., Guidance for Industry: Conducting Remote Regulatory Assessments—Questions and Answers (June 2025).
2 Id. at 6.
3 Id. at 5–6.
4 Id. at 6–7; See 21 U.S.C. § 374(a)(4); 21 C.F.R. §§ 1.510(b)(3) and 1.512(b)(5)(ii)(C).
5 See 89 Fed. Reg. 5244, 5244 (Jan. 26, 2024) (revised draft guidance); 87 Fed. Reg. 44129, 44129 (July 2022) (original draft guidance).
6 90 Fed. Reg. at 27320.
7 See Arnold & Porter, Advisory, FDA Issues Draft Guidance Addressing Remote Regulatory Assessments (Aug. 8, 2022).
8 RRA Q&A at 8. FDA caveats that it generally does not intend to conduct an RRA during Medical Device Single Audit Program audits. Id. n.19.
9 Id. at 8.
10 U.S. Food & Drug Admin., Press Release, FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities (May 6, 2025).
11 RRA Q&A at 5 and 9.
12 Id. at 10.
13 Id. at 11.
14 Id. at 14–15.
15 Id. at 11.
16 Id. at 10.
17 Id.
18 Id. at 11 n.27.
19 Id. at 15.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
