Provided below is a history of all updates to the application software in reverse
chronological order by version number.
| Version 1.37.01 – Released September 5, 2008 |
| Enhancements |
- Added Microwave Oven Safety (Product) Report to the RadHealth Master template.
- Added Television Safety (Product) Report to the RadHealth Master template.
- Incorporated minor business rule changes to the OIVD template.
- Incorporated new hints to the e2579 Master template.
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| Fixes |
- Added a business rule to enable the Burden to Industry node on the RadHealth Master template.
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| Version 1.36.01 - Released August 5, 2008 |
| Enhancements |
- Added the e2579 Report of Diagnostic X-Ray Assembly template.
- Updated the country list used within all contacts and establishment addresses.
- Incorporated minor changes to the OIVD templates.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.35.01 |
| Enhancements |
- Updated the wording on the RadHealth Laser Light Show template to include more explicit transmission instructions.
- Updated the RadHealth General Annual Report template by removing the question "Introduction into Commerce?" from Part 3 Current Production Tabulation.
- Updated the RadHealth Master template by modifying the wording of various questions on the Product Data tab -> Responses to Noncompliances or Defects.
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| Fixes |
- Fixed hyperlinks on the RadHealth Master template.
- Fixed the RadHealth Laser Product Report template regarding the business rule logic for 4.6 Operation and 4.7.5 Basis of Reported Value.
- Fixed the RadHealth Sunlamp Product Report template regarding the business rule logic for Part 2 Sunlamp Product Description and Part 3 Ultraviolet Lamps.
- Fixed the RadHealth Cabinet X-Ray Product Report template regarding the business rule logic for sections 5.4 - 5.6 Apertures.
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| Version 1.34.01 |
| Enhancements |
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.33.01 |
| Enhancements |
- Added a new introduction screen providing access to a variety of application messages that previously were only available from a series of individual popup dialogs or the CeSub website. The various messages include the following information:
- Welcome message providing a general overview of the eSubmitter application.
- Alerts and News with potential concerns and issues as well as new and upcoming features.
- Helpful Tips providing additional guidance.
- Address and Contact information.
- Links for getting additional information.
- Frequently asked questions related to what users have commonly asked.
- History detailing application updates.
- Added a new and improved submission creation wizard, see the "news" in the new introduction screen for details.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.32.01 |
| Enhancements |
- Added a new Specimen Collection Template for OIVD submissions.
- Adjusted the formatting of the model family and model name contained within the Rad Health Submittal Letter.
- Updated the Med Watch 3500A template so that Form Codes are properly validated against a predefined list.
- Updated the Med Watch 3500A template so that file attachments are on their own node and are no longer a part of the H10 and H11 responses.
- Updated the submission report so that disabled nodes are no longer printed.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
- Fixed an issue where file attachments were incorrectly displaying a numeric key value in the table view of a tabular node instead of the file title.
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| Version 1.31.02 |
| Enhancements |
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| Fixes |
- Fixed an issue related to producing the Med Watch 3500A report output that also impacted packaging.
- Fixed an issue where in some cases the establishment and contact information would not copy from a question response to the address books.
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| Version 1.31.01 |
| Enhancements |
- Updated the Rad Health general template to include several product code enhancements for the Abbreviated Product Report.
- Updated the variance pick list within the Rad Health general template to include additional CFR Citations.
- Enhanced the OIVD Submittal Letter to display the Applicant Correspondent (secondary contact) when included in a 510(k) submission.
- Enhanced the Contact Information section in the OIVD template to include an optional manufacturing location as well as an improved contact question type for the primary and secondary contacts.
- Added a File Attachment Question to the Special 510(k) Template to allow users to attach a sponsor generated Risk Management Chart.
- Added the 3500A PDF report to the submission package when submitting a Med Watch form.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
- Fixed an issue where partially filled in international phone/fax numbers caused an error during the packaging of Med Watch forms.
- Fixed a business rule issue in the OIVD template to properly disable the section for "Calibrators and Controls" when the product being reported includes the calibrators and controls.
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| Version 1.30.01 |
| Enhancements |
- Updated the Med Watch (3500A) template to include the following:
- New submission report output that is similar in structure to the standard 3500A form.
- New Form Code entry for organizations that have an FDA assigned Form Code.
- New User Facility and Importer support.
- Changed Report Number data entry to default to the CFN structure instead of the FEI structure.
- Changed Report Number data entry to only auto-fill the last section (i.e., sequence number). Previously, the FEI/CFN and year sections were auto-filled if entered with an incomplete number.
- Enhanced HTML responses to remove extraneous blank lines whether entered in manually or included within a copy and paste from another application.
- Updated product code, guidance, and standards lookup tables.
|
| Fixes |
- Fixed the Rad Health Submittal Letter to include a more detailed description of the selected Laser Light Show Submission type.
- Fixed issue where contact mailing phone and fax information were not being saved properly.
- Fixed issue where HTML responses pasted from Word failed to adequately filter out Microsoft Smart Tags.
- Fixed issue where sometimes the next keystroke was ignored when closing an invalid data dialog and returning to data entry control.
- Fixed issue where file attachment question counts were incorrect when included within a tabular node.
- Fixed issue where the file name could contain illegal characters when creating a submission file, saving a submission file to another name, and overriding the submission package name.
- Fixed issue from the last build where data entered into free-form text controls was sometimes not output within the report.
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| Version 1.29.01 |
| Enhancements |
- Updated the ODE Administrative Template to include the following:
- New Submission Type to allow for a 510(k) and CLIA Waiver Combination submission.
- Enhanced the ODE Administrative Template to include a link to FDA Form #3654 Standards Data Report.
- Enhanced the ODE Administrative Template to include a new section for Certification of Compliance with Clinical Trials.
- Updated the OIVD templates to address issues with business rule logic.
- Updated the Cabinet X-Ray Product Report template by including helpful hints in various sections.
- Added ZIP file support to the list of valid file types for attaching as a response to a question.
- Updated product code, guidance, and standards lookup tables.
|
| Fixes |
- Fixed the Cabinet X-Ray Product Report template regarding incorrect business rule logic.
- Fixed the number of required entries in the tabular nodes within the Diagnostic X-Ray Major Components Product Report template.
- Fixed the issue where HTML responses incorrectly added additional space within the formatting of the report output.
- Fixed the issue where the changes to contact/establishment information within the address books were not available when copying into a response, after changing the data location within the application preferences.
- Fixed the issue where the "Display Definition" window would sometimes not display within the screen import capability.
- Fixed an issue where on rare occasions a business rule may not be enforced correctly when a report is first opened.
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| Version 1.28.01 |
| Enhancements |
- Adjusted the Installation process to handle Windows Vista compatibility issues.
- Added a warning at the application startup about potential Windows Vista compatibility issues.
- Updated product code, guidance, and standards lookup tables.
|
| Fixes |
- Fixed a bug related to the Output directory not always being created before adjusting user preferences or performing an import.
|
| Version 1.27.01 |
| Enhancements |
- Incorporated changes and enhancements to Rad Health Report templates.
- Added Excel Import support to select tabular data entry nodes to simplify data entry when large quantities of data are required. Initially, only available with respect to Part 3 of the General Annual Report section for Rad Health reports.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
- Fixed a bug related to hidden questions displaying within the list of a tabular data entry node when the question is hidden from the detail data entry view.
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| Version 1.26.02 |
| Enhancements |
|
| Fixes |
- Fixed bug related to several filter dialogs failing to be displayed.
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| Version 1.26.01 |
| Enhancements |
- Incorporated changes and enhancements to Rad Health Report templates.
- Enhanced the OIVD submittal letters for CLIA Waivers and CLIA Categorization Requests.
- Updated product code, guidance, and standards lookup tables.
|
| Fixes |
- Fixed the business rule logic in the OIVD Admin template to correctly enable the original submission number field based on the Submission Type selected.
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| Version 1.25.01 |
| Enhancements |
- Enhanced the Accession number question to validate and ensure accurate data entry of the Accession number.
- Incorporated changes and enhancements into the Cabinet X-Ray Product Report template.
- Updated product code, guidance, and standards lookup tables.
|
| Fixes |
- Fixed bug in the new packaging process to populate the current date on the submittal letter before the zip file has been created.
- Fixed the business rule logic in the Manufacturer’s General Annual Report template to correctly disable sections of the report based on the current production status.
- Fixed minor HL7 output issue in sections G1 and G3 of the MedWatch template.
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| Version 1.24.01 |
| Enhancements |
- Incorporated a "Save To Contact/Address Book" feature that enables address and/or contact information to be saved to the Contact/Address book from the question level.
- Enhanced the "Save As" feature to allow expired templates to be saved into the active version of templates.
- Incorporated changes to the Radiological Health Submittal Letter to display the Accession Number for Supplemental Reports.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.23.01 |
| Enhancements |
- Incorporated a new Packaging Feature to accommodate the Electronic Submission Gateway transmission approach.
- Replaced Single File Attachment Question with Multiple File Attachment Question in the Rad Health Correspondence Templates.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
- Updated the MedWatch form template with minor fixes to section D4.
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| Version 1.21.02 |
| Enhancements |
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.21.01 |
| Enhancements |
- Updated the Rad Health templates with minor changes.
- Removal of the "For CDRH Use Only" section of the Rad Health submittal letter.
- Updated the OIVD templates with minor changes.
- Updated the OIVD CLIA Waiver submittal letter to include the submission number.
- Updated product code, guidance, and standards lookup tables.
|
| Fixes |
- Minor fixes to the MedWatch Form template (information not copying when using the contact and establishment copy capability, saving of concomitant medical products and therapy dates, items required when submitting an initial vs. a follow-up report, and G3 other text not included with HL7 message).
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| Version 1.20.01 |
| Enhancements |
- Minor enhancements to the Rad Health templates.
- Minor enhancements to the OIVD templates.
- Minor changes to the MedWatch form template.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.19.01 |
| Enhancements |
- Developed an OIVD Short Form template.
- Incorporated new question type for Rad Health product codes.
- Incorporated new question type for Rad Health model designation.
- Changes to button and menu images.
- New question-level help to be added within various templates where relevant.
- Minor changes to the MedWatch form template.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.18.01 |
| Enhancements |
- Incorporated OIVD CLIA Waiver template changes.
- Incorporated minor Rad Health template changes.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.17.01 |
| Enhancements |
- Adjusted the submission letter to support CLIA templates related to OIVD reporting.
- Enhanced the Rad Health templates by increasing the number of models that can be entered.
- Enhanced the MedWatch Form 3500A template with several minor improvements.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.16.01 |
| Enhancements |
- Incorporated CLIA templates related to OIVD reporting, including a CLIA Waiver template and a CLIA Categorization Request template.
- Enhanced the Rad Health related submission letter.
- Enhanced the file attachment capability to include Excel files (.xls, .csv).
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.15.01 |
| Enhancements |
- Incorporated minor template changes.
- Updated product code, guidance, and standards lookup tables.
- Enhanced the MedWatch Form 3500A to support HL7 ICSR output.
|
| Fixes |
- Fixed international phone number and zip code formatting issues within report and letter outputs.
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| Version 1.14.01 |
| Enhancements |
- Minor enhancements to the Rad Health templates.
- Minor enhancements to the OIVD templates.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.13.01 |
| Enhancements |
- Updated various business rules and questions within the Rad Health templates.
- Included changes to the OIVD submittal letter (i.e., minor formatting and adjusted the printed address to default to an entered establishment mailing address over the entered physical address).
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.12.02 |
| Enhancements |
- Enhanced Special 510(k) template.
- Updated various business rules and questions within the Rad Health Laser Product Report template.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.12.01 |
| Enhancements |
- Enhanced Special 510(k) template to include a Risk Analysis Table.
- Enhanced Special 510(k) submittal letter to include the Declaration of Conformity.
- Enhanced supplement template to support amendments.
- Changed the address that populates the submittal letter from the physical location to the mailing address.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.11.04 |
| Enhancements |
- Updated various business rules and questions within the Rad Health templates.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.11.03 |
| Enhancements |
- Updated various business rules and questions within the Rad Health templates.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.11.02 |
| Enhancements |
- Enhanced templates to allow for bundling of OIVD submissions.
- Updated various business rules and questions within the OIVD templates.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.11.01 |
| Enhancements |
- Added the High Intensity Mercury Vapor Discharge and Metal Halide Lamp Product Report.
- Added the High Intensity Mercury Vapor Discharge and Metal Halide Lamp Annual Report.
- Updated reports (minor changes).
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.11.00 |
| Enhancements |
- Updated reports (minor changes).
- Updated product code, guidance, and standards lookup tables.
|
| Fixes |
- Updated User Guide with minor corrections to proxy setting.
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| Version 1.10.01 |
| Enhancements |
- Added the Therapy Ultrasound Product Report.
- Added the Therapy Ultrasound Annual Report.
- Updated the MedWatch 3500A and OIVD forms (minor changes).
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
|
| Version 1.10.00 |
| Enhancements |
- Added the Microwave Oven Annual Report.
- Added the MedWatch Form 3500A.
- Changed the message displayed when navigating past the first report screen (i.e., Welcome) without selecting a product type.
- Previously the message assumed "Other report" was selected, where as now it redirects the user back to the prior screen to select a product type.
- Increased the length of middle name to 15 characters (previously it only allowed a 1 character initial).
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| Fixes |
- Fixed the issue where words were the "hot-keys" for navigating between screens (Ctrl-N and Ctrl-P) were sometimes unresponsive.
- Fixed the issue where text added to top or bottom of an HTML response pasted in from an external source (e.g., Word) was inadvertently being lost when leaving the screen or application.
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| Version 1.09.00 |
| Enhancements |
|
| Fixes |
- Fixed the issue where words were inadvertently being concatenated within multi-line responses after a saved report was reopened.
- Fixed the issue where the top line within an HTML response pasted in from an external source (e.g., Word) was inadvertently being cutoff at the top.
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| Version 1.08.00 |
| Enhancements |
- Added symbol support to non-HTML based data entry fields (e.g., trademark, copyright).
- Added support for redirecting the location data and output files are stored (located under preferences).
- Added support for specifying the Adobe viewer application (located under preferences).
- Updated the OIVD and RadHealth submittal letter (minor adjustments).
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
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| Version 1.07.00 |
| Enhancements |
- Added the TV Annual Report.
- Added a warning message when opening a report where the template it was based on will become inactive within 30 days.
- Updated the User Guide.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
- Fixed issue where the last modified date of a report was incorrectly reported on the screen.
- Fixed issue where data tabs from the previous report were still visible when opening a new report.
- Fixed issue where disabled outline nodes still allowed data to be added within tabular screens.
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| Version 1.06.00 |
| Enhancements |
- Added the Accidental Radiation Occurrence Report.
- Added the General Variance Request Form.
- Added several more roles to RadHealth Main Menu.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
- Fixed business rules in the Sunlamp Product Report, OEM Report, and the Abbreviated Product Report.
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| Version 1.05.00 |
| Enhancements |
- Added a link to display guidance for entering FDA reference numbers.
- Added basic report locking capabilities for users that wish to use the application on a network.
- Added a button to the button bar for packaging a report for submission.
- Added a note to the end of RadHealth reports to remind users to package the report for submission.
- Added the application version to the data files.
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
- Fixed an issue where the cursor disappeared when tabbing through a displayed HTML table.
- Fixed an issue where the replace button was disabled during spell checking.
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| Version 1.04.00 |
| Enhancements |
- Added support for entering an FDA related identifier to a report submission. The option is located under the Tools menu and can be used to record the unique identifier assigned to a submission by FDA once it has been processed.
- Added warning text to some questions that data could be cleared if the response is changed (e.g., when changing the report type).
- Updated product code, guidance, and standards lookup tables.
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| Fixes |
- Fixed an issue related to viewing old eLaser reports where picklist data was not displaying properly.
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| Version 1.03.00 |
| Enhancements |
- Updated product code, guidance, and standards lookup tables.
|
| Fixes |
- Fixed text issue within the address state picklist.
- Fixed the issue preventing the viewing of PDF files that have an uppercase PDF file extension.
- Fixed the issue preventing phone number from printing in the submission report.
- Fixed the issues regarding illegal characters in the submission manifest file.
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| Version 1.02.00 |
| Enhancements |
- Updated product code, guidance, and standards lookup tables.
- Adjusted the file attachment responses so invalid file types are prohibited.
- Added the submitter phone number to the signature portion of RadHealth submittal letters.
- Added registration capabilities.
- Adjusted the version number of the application to distinguish major, minor, and data/template related releases (i.e., major.minor.data).
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| Fixes |
- Fixed the issue related to foreign contact information incorrectly reverting to a US structure.
- Fixed the issue preventing "NOT" from being selected as a valid product code.
- Fixed the RadHealth submittal letter so it includes a period after the product type for Annual Reports.
- Fixed the issues related to incomplete submitter foreign address information within the submittal letter.
- Fixed the issues regarding the display of numeric values within tabular screens that contain exponential information.
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| Version 1.10.00 |
| Enhancements |
- Added HTML support to free-form text entry.
- Added support for auto-saving (under preferences).
- Added a message when application updates are received and support for viewing application revisions from the Help menu.
- Added a new button and menu option to allow screens to be processed (i.e., data saved to memory and rules applied) without having to select another node or save the data to disk.
- Revised the Submission Letter content.
- Changed all output to be formatted as HTML instead of PDF.
- Revised the output dialog for HTML support (allowing the default browser or an external application to be used for viewing), including the ability to change the external application at any time.
- Added RadHealth data into the local data stores (e.g., product codes).
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| Fixes |
- Fixed issues related to foreign addresses and the contact/establishment questions and books.
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| Version 1.00.00 (Initial Release) |
