US FDA issue draft guidance for industry on conducting remote regulatory assessments

Draft guidance issued for 60-day consultation period

The US FDA has issued draft guidance, in the form of a Question and Answers document, on conducting remote regulatory assessment (RRA). The draft guidance is intended to provide transparency and greater consistency. The guidance notes that practices adopted during the pandemic for remote interactions have proven useful in reducing delays in approval or authorization of marketing submissions. They have also been valuable in:

• Assisting in verifying corrective actions taken in response to inspections of previously compliant manufacturers;
• Gaining compliance insight when not practical to perform an inspection; and,
• Providing information about deficient practices leading to inspections being conducted, deciding on future inspection scheduling, and taking regulatory actions.

The FDA have concluded that RRA should be used for certain scenarios outside of the pandemic for all types of FDA-regulated products and across all its regulated areas.

The draft guidance defines an RRA as an examination of an FDA-regulated establishment or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. It is described as a tool to support regulatory decisions and oversight activities. It is indicated that an RRA is not intended to limit or replace other established remote means of obtaining information necessary for the FDA to accomplish its public health mission outside of inspections.

The draft guidance distinguishes between an RRA and an inspection. An inspection, as described in the US Regulations, involves duly designated officers or employees of the FDA physically entering an establishment at reasonable times and in a reasonable manner. The draft guidance indicates that the FDA does not consider an RRA to satisfy statutory requirements that specify inspection. Furthermore, the FDA does not plan to conduct RRAs and inspections of a manufacturer, or other regulated organization, simultaneously. RRAs complement FDA’s authority to conduct inspections and does not limit its authority to conduct inspections.

The FDA propose to conduct an RRA, for example, when an inspection cannot be conducted due to travel limitations or:

• Preparing for an already planned inspection,
• Following up on a consumer complaint,
• Assisting in verifying that an establishment has completed corrective actions, and
• Supporting the review of marketing submissions.

The draft guidance draws a distinction between voluntary and mandatory RRAs. RRAs that are not covered by FDA’s statutory or regulatory authority are voluntary and can be declined or participation withdrawn. The draft guidance indicates that refusal of a voluntary RRA will not in itself lead to regulatory action but that the FDA will consider other tools for evaluating compliance.

During an RRA, the following can occur:

• The FDA requests and reviews records, documents, and other information (such as electronic systems, and source records from non-clinical and clinical studies).
• Virtual meetings between the FDA and responsible personnel review the information provided, the electronic systems, the establishment’s operations, or the establishment’s standard operating procedures.
• Interactions between the FDA and an establishment may continue during the course of an RRA.
• Use of livestream and/or pre-recorded video might be used to examine facilities, operations, data and information.

Upon completion of an RRA, the FDA can schedule a meeting with the establishment’s management and present a written list of any RRA observations. 

It is interesting to note how the experience gained from flexibilities introduced during the pandemic is starting to be introduced into regular practice. Manufacturers supplying the USA should review the draft guidance and consider submitting any comments before the end of September 2022.