serious adverse event

(2) Serious adverse event The term “serious adverse event” is an adverse event that— (A) results in— (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).


21 USC § 379aa-1(a)(2)

Scoping language

In this section
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