USA – FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

The purpose of this guidance is to establish procedures for submitting, reviewing and
responding to requests for information regarding the class in which a device has been
classified or the requirements applicable to a device under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) that are submitted in accordance with section 513(g) of
the FD&C Act, 21 U.S.C. 360c(g).
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic
and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance means that
something is suggested or recommended, but not required…