Lets start your PMTA application
1 Start with GAP analysis.
2 Plan , Prepare and Application Submission
3 Get your PMTA Number.
Process to get PMTA Number
Our Steps
A voluntary formal meeting between the applicant and
FDA to discuss a planned PMTA submission for a tobacco product.
A threshold determination of whether the application
contains sufficient information to permit a substantive review.
A systematic review conducted before preparing a Premarket
Tobacco Product Application (PMTA) to identify missing data, documentation, and
study requirements needed to meet the U.S. FDA’s expectations under 21 CFR Part
1114.
An initial review that ensures the product falls under
Center for Tobacco Products jurisdiction and confirms that the statutory and
regulatory requirements of an application are met based upon Section 910 of the
FD&C Act and the criteria set forth in § 1114.27(a)(1).
Postmarket reporting requirements for all products that
receive a marketing granted order are set forth in § 1114.41