FDA issues draft guidance on remote regulatory assessments

On July 22, FDA published Draft Guidance formalizing its plans to continue using remote regulatory assessments (RRAs) for FDA-regulated products outside of the current COVID-19 public health emergency.  The purpose of the Draft Guidance is to help industry understand RRAs and to facilitate more effective use of RRAs in FDA regulatory activities.¹ RRAs include remote assessments of a covered establishment and/or its records and are intended to be a supplement to onsite inspections. The term RRA describes “a category of activities for which FDA may use different terminologies,” including “remote interactive evaluations” and “remote record reviews” of covered establishments.

FDA developed RRAs as a tool to support field operations in response to travel-related restrictions during the COVID-19 pandemic. Over the last two years, FDA conducted RRAs of approximately 1,470 domestic and 600 foreign FDA-regulated establishments. According to the Draft Guidance, FDA found this tool effective in getting essential information to regulators, enabling the FDA to intervene when needed and use agency resources more efficiently to do so.² Given this record, FDA concluded that RRAs should be used for certain scenarios outside the current pandemic, and intends to consistently incorporate RRAs as a tool across all FDA-regulated products.³

Comments on this Draft Guidance should be submitted by September 23, 2022 to Federal Register Number 2022-15812.⁴ Though this Draft Guidance also covers drugs and medical devices, this update is focused on the implications for food and beverage companies.

Summary of Draft Guidance Q&A

The Draft Guidance consists of sixteen questions with detailed answers, divided into four categories (RRA fundamentals, RRA expectations, and requests for records and other information, and completion of an RRA). We address the key features from each section below:

A. RRA Fundamentals

• Definition: FDA defines an RRA as “an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements.”

• Coverage: FDA may request that any establishment participate in a voluntary RRA. Mandatory RRAs are applicable to FSVP importers, as provided by 21 CFR 1.510(b)(3) and 1.512(b)(5)(ii)(C). At this time, FDA does not accept requests to perform an RRA.

• Inspections: FDA inspections are defined to involve designated individuals “physically entering” covered establishments, so FDA will not issue a Form FDA 482 or 483 for an RRA.

• • Voluntary RRAs do not qualify as inspections. Voluntary RRAs “could precede, prompt, or be a follow-up to, an inspection” but would not be conducted concurrently with an inspection. When a voluntary RRA precedes an inspection, FDA can use information from the RRA to inform a subsequent inspection and may combine any information gained from the RRA with any resulting observations from the inspection.  FDA will confirm any observations from the RRA during the inspection before including them on a Form 483. When oversight activities are conducted by other parties (e.g., states and foreign regulatory partners), FDA may conduct RRAs (e.g. livestreaming) during these inspections.

  • Mandatory RRAs for FSVP importers have specific statutory grounding that means records requests via RRA do qualify as an inspection.

• Timing: FDA may initiate or request an RRA as “appropriate” at its discretion using a “risk-based approach.” Factors include firm location, inspection history, complexity of product, and travel restrictions.

• Benefits: FDA outlines benefits that include enhancing establishment preparedness, reducing resource expenditure, streamlining regulatory decisions, improving risk-based inspection schedules, and verifying corrective actions.

B. RRA Expectations

• Notification: For voluntary RRAs, FDA will contact the establishment’s point of contact by email or phone, as identified via registration or other information. These requests ask for a written confirmation from the establishment’s top management at the site or their senior designee, of “the establishment’s willingness and ability to participate in the type of RRA requested.” For mandatory RRAs of FSVP importers, FDA will used a Form FDA 482d.  In neither case will FDA issue a Form FDA 482, Notice of Inspection. 

• Content: RRAs may include record sharing and review, virtual meetings to discuss operations, or the “use of livestream and/or pre-recorded video . . . to examine facilities, operations, data, and information.”

• Consequences for declining: Declining a voluntary RRA will not result in an enforcement action, but it may lead to an inspection. The consequences for declining mandatory RRAs may include refusal of food offered for import by an FSVP importer.

• Technological expectations: FDA will coordinate with an establishment in advance to align on technical expectations, such as submitting records electronically. If FDA expects that the RRA could include the use of live streaming video and an establishment “is unable to support streaming video,” FDA may terminate the RRA and can turn to an alternative action.

C. Requests for Records as Part of RRAs

• Scope: For voluntary RRAs, FDA “may request records or other information” necessary to assess compliance with FDA requirements. For mandatory RRAs, FDA may request any and all records required to be maintained under 21 CFR 1, Subpart L..

• Purpose: Information and documentation obtained through an RRA may be used for  assessing compliance, determining the need for a follow-up inspection, supporting regulatory actions (e.g., regulatory meeting, warning letter, import action or recall activity), or prioritizing inspection schedules.

• Timeframe: For voluntary RRAs, FDA may suggest timeframes for responding to a records request or conducting the remote assessment. For mandatory RRAs, FDA will request a specified timeframe. Relevant factors include size of the establishment, complexity of requested records, reasons for request, and any translation requirements.

• Submission: For voluntary RRAs, requested records should be submitted electronically in English. For mandatory RRAs of FSVP importers, “records must be sent electronically, or through any other means that delivers the records promptly upon written request from FDA.”  FDA will provide a secure means to send requested records and information.  Recognizing that some records are maintained in paper format, FDA states that such documents should be scanned as search able PDF files, when possible.

D. Completion of an RRA

• Final Meeting and Observations: FDA may meet with an establishment’s management and present a written list of any RRA observations. RRA observations are defined as “conditions and/or practices observed, in the judgment of the FDA employee(s) conducting the RRA, that indicate a potential violation of the laws enforced by FDA.” FDA will not issue a Form FDA 483 for an RRA, and an RRA is not a final Agency action, but FDA may conduct an inspection or carry out any other appropriate action when significant issues are discovered. FDA encourages establishments to respond during the meeting or in writing to the observations within 15 business days.  Written lists of observations and establishment responses may be subject to request and disclosure under the Freedom of Information Act, with redaction of non-public information.

• Written Report: As part of the RRA process, FDA will ordinarily prepare a report consisting of a narrative and supporting documents that communicates the summary of information reviewed, conditions and practices found, and the observations identified. FDA will provide a written copy of the narrative portion of the RRA report to the establishment, following the determination that the RRA is closed.  At that time, the report and supporting document, with any applicable redactions, also become available for public disclosure upon request.

We will continue to monitor the progress of this Draft Guidance and other FDA communication on remote regulatory assessments. Please reach out if you have any questions on this or any other matter.

Authored by Elizabeth Fawell and Anneke Altieri.