1. Findings Congress finds as follows: (1) There is a lack of transparency and consistency concerning inspections by the Food and Drug Administration of medical device establishments around the world, which leads to inefficiencies and inconsistencies and undermines confidence in United States standards. (2) Inspections by the Food and Drug Administration of foreign device establishments are often conducted more efficiently than inspections of domestic device establishments. (3) The frequency and nature of inspections of device establishments are not consistently risk-based, and a comprehensive, transparent, risk-based approach to inspections would result in greater focus on the more significant risks to public health while reducing the burdens on establishments with a strong track record of compliance. (4) There is a lack of transparency and consistency among United States-based regional inspection offices with respect to the frequency of inspections of device establishments and the activities and concerns that trigger for-cause inspections of such establishments. (5) Greater transparency concerning the timing and nature of routine inspections of device establishments would improve the quality and efficiency of the inspection process. (6) Enhancing communications before, during, and after inspections in which deficiencies are identified, would assist the Secretary of Health and Human Services and the device industry in maintaining the safety and effectiveness of devices. (7) Guidance for device establishments is necessary to provide transparency and consistency concerning inspection-related communications. (8) Enhanced training opportunities for device establishment investigators would improve the consistency and efficiency of the device inspection process. (9) 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