| Name | The automatically-generated name of the submission template. Click to view the Properties page. |
Type | The type of template. The type is either Submission Template, or a subtype of submission template. |
Revision | The current revision of the submission template. |
Title | A descriptive name for the template. |
State | The current lifecycle state of the template:State | Description |
---|
In Work | The template can be used to create submission projects. | Draft | The template is still being defined, or for some reason should not be used for creating submission projects. |
|
Regulatory Activity | Category | The regulatory activity category, such as Initial Submission or Renewal, that this template supports. |
Sub Category | The subcategory for the above category. |
| Regulatory Category | The category, such as Drug or Medical Device, that this template is designed for. The authorization process and requirements vary for different categories. Click to view the Properties page for the category. |
Submission Type | The type of submission, such as 510K for the FDA or Centralized Procedure for the EMA, that this template will be used to create. Click to view the Properties page for the type. |
Registration Fee | The fee for submissions created based on this template. |
Description | A description of the purpose for this template. |
Owner | The person responsible for maintaining the template. Click to view the Properties page for this person. |