FDA updates guidance on remote regulatory assessments

The US Food and Drug Administration (FDA) has revised its draft guidance on remote regulatory assessments (RRAs), outlining how it plans to use both mandatory and voluntary RRAs going forward.

“FDA’s experiences have identified significant benefits in using RRAs. For instance, RRAs have assisted FDA in verifying corrective actions taken in response to inspections of previously compliant manufacturers and in gaining compliance insight when it was not practicable to inspect,” the agency wrote in the revised draft guidance. “RRAs have also provided information about deficient practices, leading FDA to take regulatory actions and/or conduct inspections, as well as informing future inspection planning.”

The revised guidance, published on 26 January 2024, provides an update to a draft guidance document issued in July 2022 (RELATED: FDA describes plans to expand remote regulatory assessments, Regulatory Focus 22 July 2022). Along with incorporating public comments, the latest guidance was revised to align with provisions of the Food and Drug Omnibus Reform Act of 2022 that make more establishments subject to mandatory records requests from the FDA.

The revised draft guidance is written in a Q&A format and addresses how FDA may initiate an RRA, what to expect during an RRA, what records may be requested, and what happens after completion of an RRA.

“The Agency is also issuing this guidance to promote greater consistency in the way RRAs are conducted, including explaining processes for responding to an RRA request, and outlining factors we use for evaluating whether an establishment has responded timely and appropriately to a mandatory request,” FDA wrote in the revised guidance.

RRAs do not limit inspections

RRAs are an entirely remote examination of an establishment and/or its records to evaluate compliance with FDA requirements, such as remote record reviews and remote interactive evaluations. RRAs may be mandatory for importers and establishments subject to section 704(a)(4) of the Food, Drug and Cosmetic Act, but are voluntary for other types of firms.

FDA clarified that RRAs are not meant to replace or limit other means of obtaining information, such as registration confirmations, product submissions, and application assessments. “Although these activities may be conducted remotely, the Agency does not consider these RRAs,” the agency wrote in the revised guidance. Additionally, RRAs are not intended to limit FDA’s inspection authority.

FDA may initiate or request an RRA when agency employees are unable to conduct an onsite inspection because of travel restrictions or when an RRA could be helpful in oversight or in support of regulatory decisions. For instance, FDA may request an RRA to follow up on a consumer complaint, to verify that a corrective action has been completed or to support the review of a marketing submission.

While an RRA may precede an inspection, prompt one, or act as a follow up to an inspection, FDA does not plan to conduct RRAs and onsite inspections simultaneously, according to the revised draft guidance. Notably, the agency does not accept requests to perform an RRA.

What to expect

RRAs may include virtual meetings with FDA to review an establishment’s electronic systems, operations or standard operating procedures, or to review information provided to the agency. A livestream or pre-recorded video could be used to examine facilities and operations.

Voluntary RRA activities can be declined without triggering an enforcement action. However, declining an RRA could result in the need for an inspection, which cannot be declined and may take longer to set up.

Record requests are likely to be similar for both voluntary and mandatory RRAs, according to the guidance. Requests for records could include:

Records of specific lots or batches and product-specific information, such as product quality reports
Summaries of batches manufactured and their disposition
Read-only access to electronic databases
Standard Operating Procedures and records on quality systems

When an RRA is completed, FDA may have a closeout meeting and present a written list of observations.

“For purposes of this guidance, RRA observations are defined as conditions and/or practices observed during the RRA that indicate, in the judgment of the FDA employee(s) conducting the RRA, a potential violation of the laws enforced by FDA. FDA does not intend to issue a Form FDA 483, Inspectional Observations, for an RRA,” FDA wrote.

In the guidance, FDA urges establishments to respond to observations during the meeting and/or to provide a written response within 15 business days. In addition to the written list of observations, FDA generally intends to prepare a report on the RRA process that includes a narrative and supporting documents.

The comment period on the revised draft guidance closes on 26 March 2024. Comments can be submitted to regulations.gov with the docket number FDA-2022-D-0810.

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