serious adverse event

(3) 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).

Source

21 USC § 379aa(a)(3)


Scoping language

None identified. Default scope is assumed to be the entire title.
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