- On July 22, the FDA published a draft guidance on conducting Remote Regulatory
Assessments. Remote Regulatory Assessments (RRAs) were originally
developed during the COVID-19 health emergency and are a set of
tools to help the Agency conduct oversight, mitigate risk, and meet
critical public health needs with respect to certain FDA-regulated
products.
- Currently, requests for records or other information from drug
establishments under section 704(a)(4) of the FD&C Act, and
requests for FSVP records under 21 CFR 1.510(b)(3) and
1.512(b)(5)(ii)(C), are RRAs that FDA conducts for which
participation is mandatory. RRAs that are not conducted under
statutory or regulatory authority are voluntary, meaning that an
establishment can decline to participate, in which case the Agency
would consider other tools for evaluating compliance with FDA
requirements.
- The draft guidance describes the FDA's current thinking on
its use of RRAs and is intended to increase the industry's
understanding of RRAs and the FDA's process for conducting
RRAs. The draft guidance provides answers to frequently asked
questions about what RRAs are, when and why FDA may use them, and
how they are conducted, among other FAQs.
- Stakeholders may submit comments on the draft guidance until September 23. Please feel free to contact Keller and Heckman at fooddrug@khlaw.com for assistance providing FDA comments.
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