{"identifier":"/us/usc/t21/s360h\u20131","title":21,"num":"\u00a7\u202f360h\u20131.","heading":"Program to improve the device recall system","text":"\u00a7\u202f360h\u20131.\nProgram to improve the device recall system\n(a)\nIn general\nThe Secretary shall\u2014\n(1) establish a program to routinely and systematically assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices;\n(2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;\n(3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall; and\n(4) document the basis for each termination by the Food and Drug Administration of a device recall.\n(b)\nAssessment content\nThe program established under subsection (a)(1) shall, at a minimum, identify\u2014\n(1) trends in the number and types of device recalls;\n(2) devices that are most frequently the subject of a recall; and\n(3) underlying causes of device recalls.\n(c)\nDefinition\nIn this section, the term \u201crecall\u201d means\u2014\n(1) the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of\nsection 360h of this title\n(2) the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under\nsection 360i(g) of this title","url":"https://projectusc.org/usc/t21/s360h\u20131.html","content":[{"t":"sec","id":"/us/usc/t21/s360h\u20131","children":[{"t":"num","text":"\u00a7\u202f360h\u20131."},{"t":"heading","text":"Program to improve the device recall system"},{"t":"subsec","id":"/us/usc/t21/s360h\u20131/a","children":[{"t":"num","text":"(a)"},{"t":"heading","text":"In general"},{"t":"chapeau","text":"The Secretary shall\u2014"},{"t":"para","id":"/us/usc/t21/s360h\u20131/a/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" establish a program to routinely and systematically assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices;","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360h\u20131/a/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360h\u20131/a/3","children":[{"t":"num","text":"(3)"},{"t":"content","text":" develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall; and","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360h\u20131/a/4","children":[{"t":"num","text":"(4)"},{"t":"content","text":" document the basis for each termination by the Food and Drug Administration of a device recall.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s360h\u20131/b","children":[{"t":"num","text":"(b)"},{"t":"heading","text":"Assessment content"},{"t":"chapeau","text":"The program established under subsection (a)(1) shall, at a minimum, identify\u2014"},{"t":"para","id":"/us/usc/t21/s360h\u20131/b/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" trends in the number and types of device recalls;","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360h\u20131/b/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" devices that are most frequently the subject of a recall; and","tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360h\u20131/b/3","children":[{"t":"num","text":"(3)"},{"t":"content","text":" underlying causes of device recalls.","tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"subsec","id":"/us/usc/t21/s360h\u20131/c","children":[{"t":"num","text":"(c)"},{"t":"heading","text":"Definition"},{"t":"chapeau","text":"In this section, the term \u201crecall\u201d means\u2014"},{"t":"para","id":"/us/usc/t21/s360h\u20131/c/1","children":[{"t":"num","text":"(1)"},{"t":"content","text":" the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of ","children":[{"t":"ref","text":"section 360h of this title","href":"/us/usc/t21/s360h","tail":"; or"}],"tail":"\n"}],"tail":"\n"},{"t":"para","id":"/us/usc/t21/s360h\u20131/c/2","children":[{"t":"num","text":"(2)"},{"t":"content","text":" the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under ","children":[{"t":"ref","text":"section 360i(g) of this title","href":"/us/usc/t21/s360i/g","tail":"."}],"tail":"\n"}],"tail":"\n"}],"tail":"\n"},{"t":"text","text":"\n"},{"t":"text","text":"\n"}]}]}