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Product Classification
Categories
Defined in 21 CFR 601.25
Defined in 21 CFR 601.25
nCategory
I: safe; effective; and not misbranded
nCategory
II: unsafe; ineffective; or misbranded
nCategory
III: data insufficient for classification
nIIIA:
thought to have favorable risk-benefit ratio; remain
on the market pending completion of testing
nIIIB:
thought to have unfavorable risk-benefit ratio;
removal from the market pending completion of testing