category A clinical trial

(2) Category A clinical trial For purposes of paragraph (1), a “category A clinical trial” means a trial of a medical device if— (A) the trial is of an experimental/investigational (category A) medical device (as defined in regulations under section 405.201 (b) of title 42, Code of Federal Regulations (as in effect as of September 1, 2003 )); (B) the trial meets criteria established by the Secretary to ensure that the trial conforms to appropriate scientific and ethical standards; and (C) in the case of a trial initiated before January 1, 2010 , the device involved in the trial has been determined by the Secretary to be intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition.

Source

42 USC § 1395y(m)(2)

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Scoping language

None identified, default scope is assumed to be the parent (part E) of this section.

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