; (C) the effects of potential manufacturing disruptions or shut-downs on potential device shortages, which may include the discontinuance of device manufacturing and marketing, or the manufacturing of device components or parts; (D) efforts to prioritize and expedite the review of submissions for devices that the Secretary has determined under section 506J(g) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356j ) to be in shortage; and (E) efforts to prioritize inspections of facilities necessary for approval or clearance of devices described in subparagraph (D); (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 device has the meaning given such term under section 506J(i)(1) of the Federal Food, Drug, and Cosmetic Act, as added by section 4131. V Emergency use of laboratory developed tests 4141. Emergency use of laboratory developed tests (a) In general For the time in which the public health emergency under section 319 of the Public Health Service Act ( 42 U.S.C. 247d ) related to the coronavirus (COVID-19), declared by the Secretary of Health and Human Services (referred to in this section as the Secretary ) on January 31, 2020, is in place (or such other period of time determined by the Secretary), tests intended to diagnose COVID–19 that are described in subsection (b) may be lawfully marketed in accordance with this section. (b) Criteria Tests described in subsection (a) may be lawfully marketed, during the period described in such subsection, if such test— (1) is developed in a State that has notified the Secretary of its intention to review tests intended to diagnose COVID-19