USFDA finalises its guidance on Conducting Remote Regulatory Assessments (RRA)

On June 26, 2025, the U.S. Food and Drug Administration (FDA) finalised its long-awaited guidance, Conducting Remote Regulatory Assessments (RRA): Questions and Answers, which builds on draft guidance issued in July 2022 and again in January 2024. The document is available here.

Here's a summary of the main points from the document.

I. Introduction to Remote Regulatory Assessments (RRAs)

Background: The FDA adapted its field activities during the COVID-19 pandemic to include remote regulatory assessments (RRAs) to ensure oversight of regulated industries while reducing the spread of the virus. RRAs are used to evaluate compliance with FDA requirements remotely.

1. Definition: RRAs encompass various activities, including remote interactive evaluations and remote record reviews.
2. Purpose: RRAs assess establishments, verify compliance, and support regulatory decisions.

Revised Guidance: This guidance finalises a revised draft, aiming to enhance industry understanding and facilitate the RRA process. II. Background and Scope of RRAs Tools for Oversight: RRAs are one of the several tools FDA uses for oversight of regulated products. Types of RRAs: These include:

• Mandatory RRAs involving record reviews under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• Mandatory reviews of records from food importers subject to the Foreign Supplier Verification Program (FSVP).
• Voluntary RRAs involving remote requests for records and/or interactive evaluations (e.g., livestreaming, teleconferences).

Benefits Identified: FDA has found RRAs beneficial for:

• Verifying corrective actions.
• Gaining compliance insights when inspections are not feasible.
• Informing regulatory actions and inspection planning.
• Supporting timely approval of marketing submissions.

Legal Basis (FD&C Act):

• Section 704(a)(4) grants the FDA authority to request records ahead of time or instead of inspections for establishments involved in manufacturing drugs or devices.
  
• Public Interest: The agency believes that RRAs benefit public health and is issuing this guidance to promote transparency.
• Consistency: The guidance aims to promote consistency in the conduct of RRAs.

III. Questions and Answers What is an RRA?

• Examination of an FDA-regulated establishment and/or its records, conducted entirely remotely.
• Supports regulatory decisions and verifies submitted information.
• It can be mandatory or voluntary, depending on the legal authority.

Who May Be Subject to an RRA? Mandatory RRAs:

• Establishments subject to section 704(a)(4) of the FD&C Act.
• Importers are subject to FSVP (Foreign Supplier Verification Programs ) under section 805 of the FD&C Act.

Voluntary RRAs:

• Any establishment subject to FDA jurisdiction, if the RRA is not mandated by statute.

Are RRAs Replacing Inspections?

• No, RRAs complement but do not replace other means of obtaining information.

Is an RRA an Inspection?

• Generally, no. An RRA does not involve physical entry into an establishment.
• Exception: Remote requests for FSVP records are considered inspections under section 805.

When May FDA Initiate an RRA?

• Whenever the FDA determines it is appropriate to fulfil regulatory responsibilities and protect public health.
• Examples include travel restrictions, elements of establishment oversight, or support for regulatory decisions.

Will FDA Use RRAs During an Inspection?

• No, FDA does not plan to conduct RRAs and physical inspections simultaneously.
• RRAs may precede or follow inspections.

What are the Benefits of an RRA?

• Remote evaluation of compliance.
• Prompt corrective actions.
• Reduced resource expenditure.
• Timely regulatory decisions.
• Improved risk-based inspection scheduling.
• Verification of corrective actions.

How May FDA Request an RRA?

• FDA will state whether the RRA is mandatory or voluntary.
• Voluntary RRAs:
• Contact establishment through point of contact (email, phone).
• Obtain consent before beginning RRA (typically in writing).
• Discuss expectations, limitations, scheduling, technological capabilities, timelines, and feedback.

Mandatory RRAs:

• Initiate request by legal authority.
• Use Form FDA 4003 to request records under section 704(a)(4) of FD&C Act.
• Provide a sufficient description of the requested records and rationale.
• Provide confirmation of receipt of records.

What Might an Establishment Expect During an RRA?

• Requests to review records and information from electronic systems.
• Virtual meetings with FDA personnel.
• Use of livestream and/or pre-recorded video.
• Updates from FDA on observations and outstanding issues.

Consequences for Declining an RRA

• Voluntary RRAs: FDA will not take enforcement action solely based on declining.
• Mandatory RRAs: Declining can result in consequences, such as being in violation of the FD&C Act.

Technological Expectations

• Vary depending on the type and scope of the RRA.
• May include electronic submission of records or live streaming video.
• FDA may inquire about IT operability, security, and privacy controls.

IV. Requests for Records or Other Information What Records May FDA Request?

• For voluntary RRAs, information to determine compliance.
• For mandatory RRAs, records subject to inspection under section 704 of the FD&C Act.
• Examples include production records, product quality reports, batch summaries, database access, and standard operating procedures.

For What Purposes May the FDA Use Records?

• Assessment of marketing submissions.
• Determination of compliance with requirements.
• Facilitation of follow-up inspections.
• Support for regulatory actions.
• Determination of inspection priorities.

Timeframe for Submitting Records

• Mandatory RRAs: Within a timeframe consistent with legal authority.
• Voluntary RRAs: FDA may suggest timeframes to ensure timely completion.
  

How to Provide Records?

• Generally, in electronic format.
• Establishments should identify any limitations on external access and ensure encrypted files can be accessed
• If documents are maintained in paper format, they should be scanned as searchable PDFs.
• Records should be in English or accompanied by an English translation.

V. Completion of a Remote Regulatory Assessment What May Occur Upon Completion?

• Closeout meeting with the establishment’s management.
• Presentation of a written list of RRA observations, if any.
  
• FDA will not issue a Form FDA 483, Inspectional Observations, for an RRA (instead uses a Form FDA 483a).
• Establishments should be aware that a written list of RRA observations may be subject to a request under the Freedom of Information Act.
• Encourages the establishments to respond during a closeout meeting.
• The RRA report and its supporting documents may also be subject to public disclosure.