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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.

Rows 1-5:Show the identifying information for an Electronic Nicotine Delivery System (ENDS), a composite device.
Rows 6-8:Show the Heating Element component of the ENDS.
Rows 9-11:Show the Battery component of the ENDS.
Rows 12-14:Show the Power Delivery Unit (PDU) component of the ENDS.

di.xpt

di.xpt

RowSTUDYIDDOMAINSPDEVIDDISEQDIPARMCDDIPARMDIVAL
1TOB08DICIG01a1MANUFManufacturerJoes Cigs USA
2TOB08DICIG01a2TRADENAMTrade NameTreetop Methol King Size
3TOB08DICIG01a3DEVTYPEDevice TypeTobacco Product
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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. 

Rows 1-5:Show the device settings for the Electronic Nicotine Delivery System (ENDS), the composite device, SPDEVID ENDS25. The DUGRPID variable groups together the settings for the ENDS device.
Rows 6-14:Show the device settings for the Heating Element device, SPDEVID HEATELM01. The DUGRPID of 2 was used to group the settings together for the Heating Element device.
Rows 15-28:Show the device settings for the Battery, SPDEVID BATT003. The DUGRPID of 3 was used to group the settings together for the Battery device.
Rows 29-38:Show the device settings for the Power Delivery Unit (PDU), SPDEVID PDU06. The DUGRPID of 4 was used to group the settings together for the PDU device.

$titleHtml

du.xpt

RowSTUDYIDDOMAINSPDEVIDDUSEQDUGRPIDDUTESTCDDUTESTDUCATDUSCATDUORRESDUORRESUDUSTRESCDUSTRESNDUSTRESU
1TOB08DU CIG01a1

Package Type CIGARETTEFILTERED, COMBUSTEDHARDPACKHARD
PACK
2TOB07DUCIG01a2

Product QuantityCIGARETTE FILTERED, COMBUSTED20CIGARETTE2020CIGARETTE
3TOB07DUCIG01a3
LENGTHLengthCIGARETTEFILTERED, COMBUSTED86.0mm86.086.0mm
4TOB07DUCIG01a4
DIAMETERDiameterCIGARETTEFILTERED, COMBUSTED26.0mm26.026.0mm
5TOB07DUCIG01a5

VentilationCIGARETTEFILTERED, COMBUSTED10.0%10.010.0%
6TOB07DUCIG01a6

Characterizing FlavorCIGARETTEFILTERED, COMBUSTEDMENTHOL



7TOB07DUCIG01a7

Heat SourceCIGARETTEFILTERED, COMBUSTED xxx



8













Dataset Debug Messages

  • There are four leading, trailing, or non-breaking spaces in the dataset.
  • There seem to be multiple domains (DU, <br/>) present in the dataset.

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.

Row 1:Shows the composite ENDS device. The PARENT variable is null and LEVEL is 1 because this device is the top-level device, not the component of any other device.
Rows 2-5:Show the components used with the Electronic Nicotine Delivery Systems (ENDS) device identified in row 1. PARENT=ENDS25 and LEVEL=2 to indicate these are components of that device.
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reldev.xpt

RowSTUDYIDSPDEVIDPARENTLEVEL
1TOB248ENDS25
1
2TOB248ATMZR01ENDS252
3TOB248HEATELM01ENDS252
4TOB248BATT003ENDS252
5TOB248PDU06ENDS252
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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