A serious adverse event under MoCRA is an adverse event that:

(A) results in:

death;
a life-threatening experience;
inpatient hospitalization;
a persistent or significant disability or incapacity;
a congenital anomaly or birth defect;
an infection; or
significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or

(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.

‘Industry Not Ready’: MoCRA Could Spell Adverse-Event Reporting Whiplash

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