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DI = TO for Tobacco Product Identifier SPDEVID = SPTOBID for Sponsor Tobacco Device Identifier DO/DU = Tobacco Design Parameters (DP) LB = Tobacco Product Testing (TT) |
This is an example for the required tobacco product categorization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Cigarette. There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco products Premarket Authorization (PMTA) and Substantial Equivalence (SE) Pathways. The applicant submitting for SE and PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.
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