This is an example for the required design parameter information in a PMTA submission for one type of tobacco product Electronic Nicotine Delivery Systems (ENDS). 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.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The Device-In-Use (DU) domain represents properties of the device as used.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
The RELDEV dataset is used to record the relationships between the ENDS device and it's components.
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