On July 22, 2022, FDA announced the availability of a draft guidance explaining its expectations for the use of remote regulatory assessments (RRAs). The draft guidance for industry, “Conducting Remote Regulatory Assessments Questions and Answers,” describes how FDA has deployed RRAs during the COVID-19 pandemic to conduct important regulatory oversight activities. Based on this experience, FDA intends to use both voluntary and mandatory RRAs, as applicable, for all types of FDA-regulated products. The draft guidance confirms that FDA views remote assessments as an additional regulatory tool and that RRAs are not generally intended to replace inspections. The draft guidance was issued to provide further transparency to stakeholders about the circumstances in which FDA plans to use this tool and promote greater consistency in the way the Agency conducts RRAs. The draft guidance covers key issues such as the following:
- What is a Remote Regulatory Assessment? How do inspections and RRAs differ?
According to the draft guidance, an RRA is “an examination of an FDA-regulated establishment and/or its records, conducted entirely remotely, to evaluate compliance with applicable FDA requirements.” As a general matter, RRAs are tools that “complement” FDA’s statutory inspectional authority but are not intended to replace inspections or limit FDA’s authority to conduct inspections. One notable exception is that Foreign Supplier Verification Program (FSVP) records requests conducted under section 805(d) of the FD&C Act and its implementing regulations are intended to function as inspections.
An RRA is distinct from an inspection in that RRAs are conducted remotely by FDA staff without FDA’s physical presence at the establishment. FDA will not issue a Form FDA 482, Notice of Inspection, or Form FDA 483, Inspectional Observations, for an RRA. However, the guidance also provides that an RRA could precede, prompt, or be a follow-up to, an inspection.
- What is the difference between a mandatory RRA and a voluntary RRA?
FDA has statutory authority to conduct two types of mandatory RRAs: (1) for drug manufacturing establishments, FDA may request records or other information under section 704(a)(4) of the FD&C Act.; (2) for food importers, FDA may request FSVP records under section 805(d) of the FD&C Act, 21 CFR 1.510(b)(3), and 1.512(b)(5)(ii)(C). These two types of RRAs are “mandatory.”
Any other RRAs that FDA conducts are “voluntary.” An establishment can decline to participate in a voluntary RRA or withdraw participation during the RRA. FDA explains that if an establishment declines to participate or withdraws from an ongoing voluntary RRA, FDA may consider other tools for evaluating compliance with FDA requirements.
- What circumstances or conditions prompt FDA to use RRAs? May I request one?
FDA intends to use a risk-based approach in deciding when to initiate or request an RRA. Among other considerations, FDA may look at the firm’s location, inspection history, complexity of product and process, and travel restrictions. The draft guidance states that the decision to deploy an RRA is ultimately a matter of FDA’s discretion and that FDA is not currently accepting requests to perform RRAs.
- How does FDA initiate or request an RRA?
Each product Center and ORA may have different processes and procedures for initiating RRAs. For voluntary RRAs, if FDA has determined that an RRA is appropriate, FDA will identify and reach out to the establishment’s point of contact, request written confirmation that the establishment is ready and willing to participate in the requested RRA, and, if confirmation is given, work with the establishment to schedule virtual interviews and meetings, confirm technological capabilities, and request records or other information for review, as appropriate. For mandatory RRAs, FDA will use either form FDA 4003 to request records or other information from drug establishments or Form FDA 482d to request FSVP records from food importers.
- What might happen during an RRA?
Depending on the type of RRA, an RRA could involve FDA’s request and review of records, documents, and other systems; meetings between FDA and site personnel; use of live streaming or pre-recorded videos for examination of facilities, operations, equipment, or information; or other activities. Technological expectations will also vary depending on the type of RRA and its scope. The draft guidance states that FDA “may” provide updates on “observations and outstanding issues” during the course of the RRA.
- What types of records and information can FDA request? How should I provide requested records and information?
For voluntary RRAs, FDA may request records or other information similar to what FDA would request during an inspection, such as those appropriate to determine whether the establishment, FDA-regulated product, or clinical study is in compliance with applicable FDA requirements. For mandatory drug establishment RRAs, FDA may request any records that it would request in an inspection under section 704(a) of the FD&C Act. For food importers, FDA may request records required in 21 CFR 1, subpart L.
For mandatory RRAs, FDA will request that records be submitted within a specified timeframe, based on the reason for the RRA (such as an application goal date), translation, the establishment’s resources and capabilities, and other factors. FDA will provide a suggested timeframe for voluntary RRAs.
Records should be submitted to FDA in an electronic format through a secure mechanism that FDA will provide. Establishments responding to RRAs should identify any access limitations on electronic records/documents and provide a means for FDA to access them. Documents that are maintained in paper format can be converted to searchable PDFs; if paper documents cannot be provided as PDFs, FDA will provide contact information for the person requesting the records. For records that are not in English, FDA may request translation. (For FSVP food importer RRAs, records must be provided in English and electronically under 21 CFR 1.510(b)(1),1.512(b)(5)(C)(ii)(A), 1.510(b)(3), and 1.512(b)(5)(ii)(C)).
- What are the potential outcomes when FDA completes an RRA?
According to the draft guidance, FDA can use the information requested in an RRA for a variety of regulatory purposes, including but not limited to assessing marketing application submissions; determining compliance with the FD&C Act or PHS Act; assessing the need for an inspection or prioritizing establishments for inspections; and supporting regulatory actions, market actions, or enforcement actions. Following an RRA, FDA may conduct an inspection. FDA may also take any other appropriate actions, including an enforcement action, when significant issues are discovered.
- Should I respond to an RRA?
At the conclusion of an RRA, FDA may hold a meeting with the establishment’s management. FDA will not present a form FDA 483, but it may provide a list of written observations from the RRA. FDA considers RRA observations to be “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.” (Note that in the case of FSVP food importer RRAs, FDA will use a Form FDA 483a, FSVP Observations.)
FDA “encourages” responses to RRAs; if establishments provide written responses within 15 business days, FDA indicates that it will “generally” consider such responses “before further Agency action or decision.” Although FDA will not prepare a formal EIR as it does with inspections, the draft guidance indicates that FDA will typically prepare a report of the RRA to summarize 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.
Stakeholders should note that while FDA does not consider a written list of RRA observations to be a final agency action or decision, such lists could be requested under the Freedom of Information Act and be made publicly available, as could any written responses that the establishment provides to FDA during or after the RRA, along with FDA’s narrative report of the RRA.
- What if I decline to participate or withdraw?
While declining a voluntary RRA will not result in any enforcement action by the Agency the draft guidance indicates declining to participate may result in FDA’s inability to complete an assessment of the establishment’s activities. This might result in the Agency’s inability to timely decide on a product marketing application, or push FDA to consider other actions to obtain additional information about the establishment, such as conducting an inspection.
As explained in the draft guidance, declining to participate in a mandatory RRA could be a violation of the FD&C Act and may be the basis for an import refusal. Establishments that withdraw participation from a mandatory RRA or refuse to provide requested records in response to a mandatory RRA request may lead to a determination that the establishment has declined to participate.
Stakeholders who wish to comment on FDA’s draft guidance should do so by September 23, 2022. While FDA works to finalize the guidance, stakeholders should assess existing internal procedures and processes regarding FDA interactions to ensure they adequately address FDA’s expectations for participating in and responding to RRAs. Stakeholders may consider reviewing existing or planned technological capabilities for livestreaming, document management/retrieval, and other systems in preparation for participation in remote assessments.
If you have any questions concerning the material discussed in this client alert, please contact the members of our firm.
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