Design Parameters Example 2

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.

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.