New Final Guidance Q&A on RRAs

07/08/2025

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In June 2025, The US Food and Drug Administration (FDA) released the final guidance titled; “Conducting Remote Regulatory Assessments Questions and Answers” to facilitate understanding about what a remote regulatory assessment (RRA) is expected from establishments when the FDA initiates or requests an RRA. RRAs were implemented in FDA regulated studies during the COVID-19 pandemic in order to maintain oversight of research conducted when in-person site visits were not permitted and now continue to be included in many studies due to their strategic and logistical benefits such as cost effectiveness and flexibility (for more information about the RRAs including their advantages and limitations, please see our previous blog post on last year’s release of the draft guidance).

The guidance includes 16 frequently asked question regarding the who, what, where, when, and whys of RRA followed by the FDA’s response and recommendations. The 16 questions are divided into 4 sections:

1. RRA Fundamentals

  • This section includes basic questions such as “What is an RRA?”, “Who is subject to Mandatory/Voluntary RRAs?”, and “Is an RRA and inspection?”. A noteworthy Q&A in this section: “What are the benefits of an RRA?” to which the FDA’s response lists multiple benefits:

    • Allowing FDA to remotely evaluate compliance,

    • Reducing resource expenditure,

    • Helping to support timely regulatory decisions,

    • Providing FDA additional information to incorporate into a risk-based schedule,

    • Assist FDA in verifying corrective actions.

2. RRA Expectations

  • The distinctions between voluntary and mandatory RRAs are well highlighted in this section as the FDAs expectation are different for each in response to questions such as; “How may the FDA request an RRA?”, “What might and establishment expect during an RRA?”, and “Are there any consequences for declining to participate in an RRA?”.

    • In general, a mandatory RRA occurs in advanced or in lieu of an inspection (such as BIMO) and apply to establishments subject to section 704(a)(4) of the FD&C Act, and requests for FSVP records under 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C).

    • Voluntary RRAs, in contrast, occur when an establishment is not subject to the above laws and regulations. The FDA may still wish to assess the establishment, however establishments are under no legal obligation to participate in such RRAs.

3. Requests for Records or Other Information as Part of an RRA

  • Most of the documents requested will be similar to those requested during regular FDA regulatory assessments such as Bioresearch Monitoring (BIMO) inspections. The questions in this section focus more on how the FDA will use these records, how they should be sent, and what the timeframe for submission is.

4. Completion of an RRA

  • The final section is a single question: “What may occur upon completion of an RRA?”. Key point in the FDA’s response includes (note that RRAs are not considered inspections by the FDA, the FDA’s response to question 6 provides the details on how the RRAs relate to formal inspections):

    • There may be a closeout meeting where any findings are addressed,

    • Unlike other inspections, the FDA does not intend to issue any form 483s as a direct result of an RRA,

    • Establishments should make an effort to respond to all observations from the RRA with 15 business days before and further actions or decisions are made.

The full guidance can be found on the FDA website and those who wish to comment may do so here. RRAs are likely here to stay as a part of FDA routine oversight assessments and, like other assessments such as BIMO, it is best practice to be prepared for when they arrive. Clinical Pathways offers multiple training and consulting service that can help establishments prepare for assessments such as RRAs. For those interested, please visit our website to see our full list of consulting services, while you are there, sign up for our free blog and newsletter to stay up to date on clinical trial related activity such as this.

-The Clinical Pathways Team

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