Adverse Event Reporting
MoCRA requires that companies report any Adverse Event to the FDA within 15 days of notification by a consumer that they experienced an Adverse Event to the company’s product.
MoCRA Compliance Lab can design an Adverse Event Reporting System for your company and interface with the FDA in reporting and responding to Adverse Events.
The FDA defines two different reactions to the use of cosmetic products:
Adverse Event: A reaction after using a cosmetic, such as a rash, redness, burn, hair loss, headache, infection, illness or any other unexpected reaction, whether or not it required medical treatment.
Serious Adverse Event: 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.
