; (2) a description of how the Food and Drug Administration proactively coordinates strategies to mitigate the consequences of the violations, slow-downs, and shut-downs described in paragraph (1) across agencies; and (3) an evaluation of changes in relevant Food and Drug Administration practices that such agency has proposed but not yet implemented. (c) Definition In this section, the term essential device has the meaning given such term under section 506J(g)(1) of the Federal Food, Drug, and Cosmetic Act, as added by section 2.