; and (ii) in each of subparagraphs (F) and (G), by inserting or essential device before the period; and (4) in subsection (c)(3)— (A) by striking or section 506C(c) and inserting , section 506C(c), or section 506J(c) ; and (B) by inserting or essential devices after drug products . 4. GAO report on intra-agency coordination (a) In general Not later than 18 months after the date of enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report examining the Food and Drug Administration's intra-agency coordination, communication, and decision making in assessing device shortages and risks associated with the supply of essential devices, and any efforts by the Food and Drug Administration to mitigate any essential device shortages or to take corrective actions. (b) Content The report shall include— (1) consideration of— (A) risks associated with violations of current good manufacturing practices; (B) corrective and preventative actions with respect to such violations requested by the Food and Drug Administration; (C) the effects of potential manufacturing disruptions or shut-downs on potential essential device shortages, including the discontinuance of essential device manufacturing and marketing; (D) efforts to prioritize review of applications for essential devices that the Secretary has determined under section 506E of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 356e ) to be in shortage; and (E) efforts to prioritize inspections of facilities necessary for approval or clearance of essential 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