Remote Regulatory Assessment Oversight Tools Piloted During the COVID-19 Pandemic Are Here to Stay

Chris Fanelli explains what the U.S. Food and Drug Administration’s new draft guidance on remote regulatory assessments means for site inspections in the future, and how manufacturing facilities can prepare for requests for Remote Regulatory Assessments.

The COVID-19 pandemic resulted in an unprecedented disruption to the FDA’s inspection program. With the vast majority of its inspectional activities suspended, the FDA was forced to pilot new and unfamiliar inspectional initiatives, including Remote Regulatory Assessments (RRAs).

On July 22, the FDA released new draft guidance (the RRA Guidance), which sets out the U.S. regulator’s plan to continue to use these alternative inspectional initiatives beyond the COVID-19 pandemic. This reflects the agency’s shift toward a modernized approach to the oversight of FDA-regulated products and establishments.

The FDA’s formal adoption of the guidance on RRAs as an oversight tool will allow the agency to prioritize resources in a risk-based manner for a targeted onsite inspectional approach, and to use records obtained through RRAs to prepare for onsite inspections. It will also potentially create an additional regulatory step for manufacturers looking to demonstrate ongoing compliance.

Managing and responding to an RRA request differs significantly from managing an inspection and responding to an FDA 483, and manufacturers will need to adjust their approach accordingly. On the one hand, the increased use of RRAs will allow the FDA to conduct more targeted, onsite inspections and to more nimbly navigate shortages and potential shortages. On the other hand, RRAs could lead to enhanced scrutiny of critical, especially foreign, manufacturing sites and additional layers of FDA oversight of manufacturers overall.

The RRA Guidance explains that an RRA may include a combination of record requests, virtual meetings with the establishment, and/or the use of live stream to examine the facility’s data, operations, and information. It also makes clear that the FDA will not consider any requests to conduct inspections as an RRA and does not consider RRAs to be replacements for inspections,

In addition, the RRA Guidance sets out the conditions for voluntary and mandatory RRAs, and explains the potential benefits of having RRAs precede inspections. Manufacturers will need to balance the benefits of participation in voluntary RRAs against the burden of responding to what can end up being multiple rounds of information requests, and the potential that an RRA might lead to action by the FDA. Manufacturers should therefore assess their existing processes and technological capabilities to ensure their readiness for such requests. This will ensure that RRAs are handled with a similar level of professionalism, diligence, and urgency to onsite inspections.

For a more detailed analysis of the content of the RRA Guidance, see here.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.