devices and device types that meet one or more of the following criteria: (i) Devices and device types for which the collection and analysis of real world evidence regarding a device's safety and effectiveness is likely to advance public health. (ii) Devices and device types that are widely used. (iii) Devices and device types, the failure of which has significant health consequences. (iv) Devices and device types for which the Secretary has received public recommendations in accordance with paragraph (2)(B) and has determined to meet one of the criteria under clauses (i) through (iii) and is appropriate for a project under this subsection. (2) Participation The Secretary shall establish the conditions and processes for— (A) authorizing voluntary participation of a manufacturer of a device in the pilot project described in paragraph (1)