serious adverse event

(3)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

In this section
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