1. New Product
Market date?
No
Grandfathered
Ppredicate product?
Yes
Change?
No
Substantial Equivalence
Report (SE)
Premarket Tobacco
Product Application
(PMTA)
Label
SameCharacteristics SE
Report
Quantity
Product Change
Quantity SE Report
No Change
Supplier
Does the change by the
supplier still have the same
specs?
Yes
No
Premarket Tobacco
Product Application
(PMTA)
No Action Required
FDA Decision Tree
Was Product on theMarket before February 15,
2007?
Is there a similar product by a different
manufacturer? Does the new product have a
predicate product by Cyclops Vapor?
Change to label, quantity, or supplier?
Abbreviated reports assume that Cyclops Vapor
has previously submitted documentation and
only the label or the quantity has changed.
Changes should not make the product appear as
a different product.
No Change