FDA’s Remote Regulatory Assessment (RRA) Guidance Update
In our industry, the Food and Drug Administration (FDA) typically inspects establishments onsite, unannounced or announced, with an in-person inspector(s). Six (6) years ago, the Coronavirus Disease 2019 (COVID-19) pandemic swept through and forced business strategies to change. During this time, the Food and Drug Administration (FDA) also had to adapt its field operations to continue providing oversight in our industries. What options did they have to mitigate and prevent the spread of COVID-19 due to travel restrictions while still being vigilant in protecting public health and ensuring product compliance? Remote Regulatory Assessments (RRA)! RRAs were used to assess establishments and their compliance with FDA requirements (but note – this does not replace a physical inspection). An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements [1].
So, what’s the current thinking and why is this important? On June 26, 2025, FDA released their final guidance “Conducting Remote Regulatory Assessments” which was updated based on the Food and Drug Omnibus Reform Act in 2022 including a draft guidance published January 2024. Per the FDA, the changes include:
Distinguishing more clearly between mandatory and voluntary RRA requests;
Clarifying how FDA intends to inform establishments of the terms of participation involuntary RRAs and obtain their consent;
Facilitating transparency and consistency in FDA’s use of RRAs across regulated products, as applicable;
Clarifying mechanisms for electronic records reviews and conditions under which live data access might occur; and
Addressing concerns about confidentiality and security of information reviewed by FDA.
In general, FDA uses a multi-effort to provide a robust risk assessment to ensure safety of foods, drugs, and medical products [2] with the following but not limited to:
Onsite inspections of establishment facilities nationwide and internationally.
Investigating (including criminal investigations) fraudulent and other criminal activities that threaten public health.
Performing laboratory tests of potentially harmful foods, drugs, and medical products.
Screening all imports related to food, drug, and medical products coming into the United States.
Remote Regulatory Assessments to ensure industry compliance, remotely and safely where travel restrictions occur
Using information from capable foreign regulatory partners where there are mutual recognition agreements for drugs
Using information from trusted foreign regulatory partners under the single audit program for medical devices
Using information from trusted foreign regulatory partners where the U.S. has systems recognition for foods.
Remote Regulatory Assessments [3] include requests for record review and other information under existing statutory or regulatory authority, and voluntary interactive evaluations (i.e., remote livestreaming video of operations, teleconferences, and screen sharing). There are two types of RRA: Mandatory Assessments which include Human/Animal Drugs, Biologics, Medical Device, and Foreign Supplier Verification Program for imported foods and Voluntary Assessments which include all FDA regulated commodities.
The FDA uses RRAs where appropriate to assess compliance where it may enable an establishment to make corrective actions prior to their next inspection. It also allows the FDA to assess the adequacy of corrective actions implement from previous inspections of compliant establishments (this may push the next reinspection time out or shorten the time of the next inspection, which would speed up regulatory decisions). This also allows FDA to identify any unreported adverse events or incomplete corrective actions that resulted, and regulatory action is necessary.
Due to FDA’s success using these tools, RRAs will continue being used as applicable, to help protect public health and ensure regulated products are safe and effective. So if they reach out to conduct an inspection remotely, remember to have tools ready to support this process!
You can view the guidance document for “Conducting Remote Regulatory Assessments Questions and Answers” here [4] : RRA Q&A.
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