There is a lack of transparency in the export certification process with respect to device establishments for which FDA Form 483 has been used to document issues noticed during an inspection conducted pursuant to section 704 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 374 ) or establishments that have received Warning Letters in connection with such an inspection, and between domestic and foreign establishments, resulting in devices that are lawfully marketed for United States patients being denied certification for marketing in other countries. (10) Device establishments that have attempted to address deficiencies identified by inspections carried out by the Food and Drug Administration lack sufficient opportunities to confirm that such corrective actions are appropriate. 2. Risk-based inspections for devices Paragraph (2) of section 510(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(h) ) is amended to read as follows: (2) Risk-based schedule for devices (A) In general The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph (1) that are engaged in the manufacture, propagation, compounding, or processing of a device or devices (referred to in this subsection as device establishments ) in accordance with one risk-based inspection schedule established by the Secretary, applied consistently across regional offices. (B) Factors and considerations In establishing the risk-based schedule under subparagraph (A), the Secretary shall— (i) apply, to the extent applicable for device establishments, the factors identified in paragraph (4)