Navigating the Regulatory Landscape in the Digital Age: A Guide to FDA’s New Guidance on Remote Regulatory Assessments

On January 26, 2024, the U.S. Food and Drug Administration (FDA) published a new draft guidance on remote regulatory assessments (RRAs). This guidance, “Conducting Remote Regulatory Assessments — Question and Answers,” represents the Agency’s current approach to the use of RRAs, including when and how FDA will conduct RRAs, how companies should respond, how FDA will use RRAs, and the potential consequences for refusing a remote inspection.

Background

During the COVID-19 epidemic, FDA introduced RRAs to provide oversight when travel restrictions prevented FDA from conducting on-site inspections. FDA released draft guidance, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency,” in April 2021, which was updated in October 2023.¹ In July 2022, FDA released “Conducting Remote Regulatory Assessments—Questions and Answers Draft Guidance for Industry”. This newest draft guidance with the same title is an update to the July 2022 guidance, which discusses how FDA will use RRA on a going-forward basis and also provides answers to frequently asked questions about the RRA process.

Remote Regulatory Assessments (RRAs)

An RRA is an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements. The Agency clarifies in the draft guidance that an RRA is not considered an “inspection,” which involves the physical on-site presence of FDA officials. FDA emphasizes that RRAs complement FDA’s existing authority to conduct inspections under Section 704(a)(1) of the Federal Food Drug and Cosmetic Act (FDCA) but do not limit FDA authority to conduct in-person inspections.

Types of RRAs

RRAs can be either mandatory or voluntary.

Mandatory RRAs are conducted for establishments subject to Section 704(a)(4) of the FDCA (i.e., drug establishments) and importers as defined in 21 CFR 1.500 that are subject to the Foreign Supplier Verification Program (FSVP) under Section 805(d) of the FDCA. When initiating a mandatory RRA, FDA informs the establishment of the section under which the mandatory RRA is requested.

• For drug establishments, FDA issues a Form 4003 FDA Inspection Records Request, or uses a similar method, to request records or other information. The guidance notes that FDA would provide a sufficient description of the records/information requested and rationale for requesting these records in advance of or in lieu of an inspection.
• Importers subject to the FSVP would receive notification from FDA with Form FDA 482d Request for FSVP Records for imported foods.

Note that failing to respond, withdrawing participation, and/or refusing to provide records upon a lawful request may be viewed as a violation and considered a refusal under Section 301(e) or (f), or 807, of the Act. The guidance states that FDA intends to take appropriate action against persons and products that are in violation of the Act. FDA can use mandatory RRAs alone to take enforcement action. Actions² can include and are not limited to warning letters, import alerts, and refusal of product offered for import into the U.S.

Voluntary RRAs are not mandated by statute or regulation. Any type of establishment regulated by FDA can be contacted for a request to participate in a voluntary RRA. FDA would notify the establishment by phone, email, or letter and include the purpose and planned scope of the RRA and the right to refuse to participate in the voluntary RRA. Declining a voluntary RRA will not result in enforcement action; however, it may take FDA longer to assess an establishment when factors prevent FDA from conducting a timely on-site inspection.

How FDA Will Use RRAs

Regulatory purposes of an RRA can include the evaluation of establishments for pending market submissions; determining compliance with Federal Food, Drug, and Cosmetic Act (FDCA) or Public Health Service Act requirements; assessing the need for inspection follow-up to a reported concern or defect; supporting enforcement actions (e.g., regulatory meeting, warning letter, import action, recalls); and determining the priority of establishments for inspections (particularly surveillance).

FDA notes in the draft guidance that it does not plan to conduct RRAs and on-site inspections simultaneously. However, an RRA could precede, prompt, or be a follow-up to an inspection. When an RRA precedes an inspection, FDA will generally conclude the RRA prior to initiating the inspection. FDA would confirm RRA observations during the subsequent inspection and potentially include them on the Form FDA 483. FDA may also use an RRA to assist in verifying corrective actions from an inspection.

RRAs can include the following:

• review of records and other information (such as electronic systems);
• virtual meetings with the site to review electronic systems, operations, and/or standard operating procedures; and/or
• use of livestream and/or prerecorded video to examine facilities, operations, data, and other information.

Conclusion of an RRA

As with an on-site inspection, at the conclusion of an RRA, FDA may conduct a closeout meeting with site management. At that meeting, FDA may present a written list of observations, defined in the draft guidance as observed conditions and/or practices that, in the judgment of the FDA employee(s) conducting the RRA, indicate a potential violation of the laws enforced by FDA. Notably, FDA does not intend to issue a Form FDA 483 Inspectional Observations at the conclusion of an RRA.

Nonetheless, FDA encourages establishments to respond during the meeting and/or provide written responses to the RRA observations within 15 U.S. business days. Responses or corrective actions submitted to FDA during that timeframe generally will be considered before further Agency action or decision. When FDA considers the RRA closed, FDA will provide a written copy of the narrative portion of the RRA report to the company — a process similar to the Establishment Inspection Report following an on-site inspection. FDA notes that once the RRA is closed, the report and supporting documents, with any applicable redactions, are available for public disclosure upon request.

¹ Sidley’s update about FDA’s October 2023 remote interactive evaluation guidance can be found here.

² FDA issued warning letters to drug establishments from 2021 to 2023 for violation of Section 301(e) of the Act when they failed to respond to FDA records requests under Section 704(a)(4) of the Act. FDA also issued import alerts in 2023 based solely on information provided in an RRA.