This post was written by Paul Sheives. FDA has published two draft guidance documents relating to requests under section 513(g) of the Federal Food, Drug, and Cosmetic Act, which provides a means to obtain the FDA’s views about the classification and regulatory requirements that may apply to a particular device. In the first draft guidance, FDA discusses procedures for submitting, reviewing, and responding to requests for information under Section 513(g). The second draft guidance document discusses the user fees associated with requests under Section 513(g). FDA is accepting comments on these guidance documents until June 28, 2010.