Based on the experience and impact of Covid-19, US FDA recognizes that Remote Regulatory Assessments (RRA) can play an essential role in easing limitations that such uncontrollable factors may bring along. Therefore, FDA has published this draft to explain RRA and FDA’s regulatory requirements for RRA in the future.
RRA can be identified as two primary types "remote interactive evaluations" and “remote record reviews." Both are an examination of an FDA-regulated establishment and/or its records conducted remotely to evaluate compliance with applicable FDA requirements and to support FDA’s regulatory decisions and oversight activities.
When does FDA may request RRA?
1. Any pandemic or natural disasters, which results in FDA not being able to complete the inspections as intended.
2. When FDA determines that an RRA would reasonable assist FDA in conducting elements that may support regulatory decisions.
Hence, when either of the two aspects are given, FDA may actively implement Voluntary or Mandatory RRA as deemed necessary.
Conducting Remote Regulatory Assessments Questions and Answers Draft Guidance for Industry