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Guidance Issuing OfficeOffice of Regulatory Affairs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Conducting Remote Regulatory Assessments--Question and Answers.” FDA is issuing the draft guidance to describe the Agency’s current thinking regarding its use of remote regulatory assessments (RRAs) in order to increase industry’s understanding of RRAs and facilitate FDA’s process for conducting RRAs. FDA has used RRAs to conduct oversight, mitigate risk, meet critical public health needs and help maximize compliance of FDA-regulated products. This draft guidance provides answers to frequently asked questions regarding what RRAs are, when and why FDA may use them, and how FDA may conduct them, among others.
This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Conducting Remote Regulatory Assessments.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-0810.