Performance standards

A performance standard established under subsection (b) for a device— shall, where necessary to provide reasonable assurance of its safe and effective performance, include— In carrying out his duties under this subsection and subsection (b), the Secretary shall, to the maximum extent practicable— A notice of proposed rulemaking for the establishment or amendment of a performance standard for a device shall— The Secretary— Not later than 60 calendar days after the Secretary receives such a request, the Secretary shall— Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds— The Secretary shall establish a program under which— The Secretary may— following such review, take additional measures under this chapter, as the Secretary determines appropriate, such as— if the Secretary becomes aware of information materially bearing on the safety or effectiveness of a device for which an assessment of conformity was supported by testing conducted by a testing laboratory accredited under this subsection, take such additional measures under this chapter, as the Secretary determines appropriate, such as— The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the program under this subsection.