Appendix A in Revised- eSubmissions FILE FORMATS AND SPECIFICATIONS (fda.gov)
MODULE 3: PRODUCT DESCRIPTION AND MANUFACTURING
3.1 Product Design and Specification
3.2 Ingredients, Additives, and Constituents
3.3 Product Performance
3.4 Tobacco Product Comparisons
3.5 Tobacco Product Manufacture
3.6 Other Tobacco Product Features
3.7 Referenced Literature
From Scoping
| Category | Subcategory/Study type | Priorities |
| PRODUCT DESCRIPTION | Ingredients, Additives, and Constituents | (1) List of chemical constituents |
| PRODUCT DESCRIPTION | Ingredients, Additives, and Constituents | (2) Composition of finished product |
| PRODUCT DESCRIPTION | Ingredients, Additives, and Constituents | (12) Product chemical make-up |
| PRODUCT DESCRIPTION | Harmful and Potentially Harmful Constituents (HPHCs) | (1) List of chemical constituents |
| PRODUCT DESCRIPTION | Generalized Product Characterization | (6) Device physical attributes/functionality |
| PRODUCT DESCRIPTION | Generalized Product Characterization | (6) Device in use measurements |
| PRODUCT DESCRIPTION | Generalized Product Characterization | (6) Device make/model identifiers |
| PRODUCT DESCRIPTION | Generalized Product Characterization | (6) Device manual |
| PRODUCT DESCRIPTION | Stability Studies | (1) List of chemical constituents |
| PRODUCT DESCRIPTION | Stability Studies | (2) Tobacco product components |
Draft
Overview
Content Tools