FDA expands Remote Regulatory Assessments

Recommendation

7/8 May 2024

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In response to the Covid-19 pandemic, the FDA had adapted its workflows for on-site inspections. In view of the travel restrictions, the authority also used various types of remote assessments, summarised under the term Remote Regulatory Assessments (RRAs). RRAs were mainly used to support submissions or applications assessments of FDA-regulated products and to reduce delays. RRAs include activities for which the FDA may use different terminology, such as "remote interactive evaluations" and "remote record reviews".

Now the FDA also wants to use RRAs for certain scenarios independent of the current pandemic situation and for all types of FDA-regulated products. According to the FDA, experience to date has shown that the use of RRAs has a number of benefits, including in terms of corrective actions following an inspection or simply in gaining knowledge about a site's compliance when an on-site inspection was not possible. Similarly, observations were made in the course of conducted RRAs that prompted the FDA to take further regulatory action, conduct inspections and support the planning of future inspections.

For future implementation, the FDA has now developed and published a Draft Guidance for Industry: Conducting Remote Regulatory Assessments - Questions and Answers. This document is intended to provide answers to frequently asked questions related to RRAs and ultimately facilitate FDA's process for conducting remote assessments.

Two interesting questions (and answers) are:

Is an RRA an inspection?

No, in general, an inspection, as defined in Section 704(a)(1) of the FD&C Act, involves the physical entry (at reasonable times and in a reasonable manner) of establishments by designated FDA officials or employees. For this reason, FDA does not presume that an RRA meets the statutory requirements for an inspection.

Will FDA use RRAs during or as part of an FDA inspection of an establishment?

No, currently the FDA does not plan to conduct RRAs and inspections of an establishment at the same time. An RRA is conducted remotely by FDA staff without FDA staff being present at an establishment. However, an RRA may precede an inspection. In that case, the FDA will usually complete the RRA before initiating the inspection. The FDA may combine any information obtained from the RRA with observations from the subsequent inspection. In such a case, the authority would confirm all observations from the RRA during the inspection before including them on the FDA 483 Inspectional Observations form. In addition, the FDA may also conduct an RRA following an inspection to follow up with the establishment or verify corrective actions, as appropriate.