Page History

This is an example for the required design parameter information in a PMTA submission 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 PMTA Final Rule. The applicant submitting for PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results for all these parameters.

Device Identifiers (DI) is a study reference dataset that provides a mechanism for uniquely identifying a device. The primary purpose of this dataset is to provide a list of the devices used in a study and to provide identifying information for each device, such as device type, manufacturer, model name, etc., as applicable. All identifying information is grouped by the Sponsor Device Identifier (SPDEVID), a consistent variable, that is available for use in other domains where data pertaining to the device may be found.

...

...

illustrates the representation of a cigarette product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors. 

The manufacturing parameter specifications of the cigarette tobacco product as intended for use are represented in the PD domain  The following example shows the target, minimum, and maximum values associated with each of 23 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

Note the use of the variable IGDCMPID (Ingredient or Component Identifier) in rows 5-6. This tobacco product had 2 tobacco ingredients with 2 different tobacco cut sizes. IGDCMPID identifies to which tobacco ingredient the cut size applies. IGDCMPID originates in the IT (Tobacco Ingredients) and IN (Non-Tobacco Ingredients) domains. See Section 3.1.3.1, Ingredients and Additives, for more information.

Finally, the PT domain is used to represent the actual results of testing the manufactured cigarette product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a Required variable and is set to "DESIGN PARAMETER TESTING" for all records here. As described in the PD example, IGDCMPID is also used here to differentiate 2 records of the same test performed on each of 2 different types of tobacco that are ingredients of the tobacco product. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.

...

The Device-In-Use (DU) domain represents properties of the device as used. The DU domain now contains information that was previously found in the Device Properties (DO) domain).  The domain now captures characteristics and properties of a device that do not change and can include characteristics and properties that can vary from subject to subject (not applicable here but added for reviewers comprehension). This is a findings domain and defines important characteristics of a device that the sponsor wishes to include in the submission but do not form part of the unique sponsor-defined identification of the device. Each property is identified using controlled terminology and is stored in DUTESTCD/DUTEST.