FDA Draft Guidance - Conducting Remote Regulatory Assessments Questions and Answers

The FDA has released the draft guidance, “Conducting Remote Regulatory Assessments Questions and Answers,” which is intended to provide transparency to stakeholders about how RRAs may be used and to promote consistency in the way RRAs are conducted. The draft guidance covers voluntary and statutorily authorized RRAs but does not change the core requirements of inspections and pre- and post-market authorities.

I strongly recommend folks read this, ask questions, and we can consolidate and submit as part of the comment cycle.

3 Replies

@Jeremiah Genest thank you, Jeremiah! Do you have a link to the site where we can download the document?

@Kim K Burson Thank you: Actually, Jeremiah had included the link but was only visible on the notification email, not in this post. I was able to take a look at this morning. thanks anyway!