In June 2025, the FDA announced the availability of a final guidance document containing questions and answers on conducting remote regulatory assessments (RRAs). Any examination, that is not on site, of the compliance of an agency-regulated establishment, or its records, is an RRA. The background section points out that they may request any records or other information in advance, or in lieu, of an inspection.
An RRA is not an inspection. The agency continues to use ‘inspection’ to refer to being physically present, although in a world of remote workers and cloud based services, the word must be understood to mean more than an investigator knocking on the reception door. Since RRAs are not inspections there won’t be a Form FDA 482 in advance, and there won’t be a Form FDA 483 at the end. Instead, you may receive a Form FDA 4003 and perhaps a written list of RRA observations. Following an RRA, the agency may decide to conduct an inspection or may consider enforcement actions.
The guidance makes clear that cooperation with some RRAs will be mandatory. The experience of being required to demonstrate compliance with applicable legislation for the purposes described in question 13 might feel quite like an inspection. At other times, participation in an RRA may be voluntary. But beware failing to volunteer may lead the agency to consider other actions necessary to exercise their oversight responsibilities.
Several reasons are highlighted to explain why RRAs exist. These range from outlining how handy it was that FDA staff didn’t have to travel when that was not practical during the pandemic, the reduced logistical burden of international travel and simply being less burdensome on everyone, to enabling a more risk-based approach to inspection planning.
The Q&A describes that RRAs can be used in advance or after inspections, but not alongside at the same time. This will presumably allow the investigators to be forewarned, forearmed, and more focused. And will allow the agency to follow up on commitments and corrective actions without justifying another whole inspection. RRAs can also be used in response to consumer complaints. The overall picture given is that the agency can be more nimble, agile, and reactive.
It’s worth noting that RRAs do not limit the agency’s authority conduct inspections, so whilst they don’t plan to run them at the same time, it’s not strictly excluded.Â
One area that organisations will want to consider is how much notice they will be given to provide records, which will also be relevant to how much notice of an RRA is received. For food importing the timeframe is 72 hours to provide a response. For drugs and devices, the example given in the footnote is that the agency should give a ‘reasonable’ amount of time. This is further clarified as 15 days, or 30 days if translation is required. But it may be less than that if a specific request is time sensitive. Taken all together, this would seem to reinforce the need to be inspection (and remote assessment) ready at all times.
Author: Daniel Bennett
