The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco establishments and/or their records conducted entirely remotely without FDA's physical presence—signaling confidence and likely greater usage of RRAs to support regulatory decisions and oversight activities.

On January 26, 2024, FDA issued revised draft guidance on RRAs. The draft guidance explains what RRAs are, when and why they may be used, how FDA may conduct them, and differences between voluntary and mandatory RRAs, among other topics.

An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely without FDA staff being physically present onsite. FDA utilized RRAs during COVID and intends to continue doing so to support regulatory decisions and oversight activities. RRAs complement—but do not limit—FDA's authority to conduct inspections under the Federal Food, Drug, and Cosmetic Act ("FD&C Act") and other applicable authorities. 

An RRA is not an official inspection but could precede, prompt, or be a follow-up to one. When an RRA precedes an inspection, FDA will generally conclude the RRA before initiating the inspection and may combine information gained from the RRA with resulting observations from the inspection. Additionally, FDA may initiate a post-inspection RRA to conduct follow-up activities or assist in verifying corrective actions. 

FDA intends to use a risk-based approach to determine whether to initiate or request an RRA. Declining to participate in a voluntary RRA will not result in enforcement action but may prompt additional oversight, such as a formal inspection. 

FDA conducts mandatory RRAs for certain establishments under the FD&C Act (drug, devices, bioresearch monitoring establishments, and certain food establishments). For voluntary RRAs, FDA may request records or other information appropriate to determine whether an establishment or FDA-regulated product or clinical study is in compliance with applicable requirements.

Examples of records or other information FDA may request during a voluntary or mandatory RRA include, but are not limited to:

  • Records of specific production lots or batches as well as product-specific information;
  • Certain summaries or lists of records;
  • Read-only access to electronic databases; and
  • Standard operating procedures and records documenting control of quality systems and/or demonstrating compliance with applicable FDA requirements.

Regulated establishments may consider how they document and maintain compliance materials, given more remote interactions with the agency.

Comments and suggestions to the draft guidance should be submitted by March 26, 2024.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.