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U.S. Department of Health and Human Services

For Industry

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Application History Archive

The following is an archive of previous updates to the eSubmitter software. More recent updates are listed on the Application History page.

Version 1.81.01 - Released April 10, 2012
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed a validation issue regarding the import of numeric responses within tabular screens.
Version 1.80.01 - Released March 6, 2012
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CBER: Business rules amended to eliminate instances of data being cleared in SOP templates.
  • CBER: HTML question properties updated to display output correctly in Submission Report PDF. Corrected items include fonts, lists, and tables in HTML question outputs.
  • CVM ONADE: CORE Questions has been updated so that users can no longer submit any User Fee Waiver submissions. These templates are no long accessible in eSubmitter.
Version 1.79.01 - Released February 6, 2012
Enhancements
  • CTP: The Tobacco Product Ingredient Listing has been updated to include additional questions that will support a more structured approach to entering ingredient quantity data. This will affect your existing import spreadsheets and a new import template has been provided.
  • CTP: All CTP Submission Types now have the ability to break up large submissions into multiple submission packages. In the event your submission reached the threshold, you will be notified at the time of packaging. Please continue to submit the packages per your usual method (e.g., ESG or CD).
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.78.01 - Released January 9, 2012
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • CBER: Minor bug fixes in "SOPs - General (Automated)" template.
Version 1.77.01 - Released December 5, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.76.01 - Released November 4, 2011
Enhancements
  • CBER Electronic Submission Checklist updated to reflect new address for the Office of Regional Operations. This is the address where the sponsor should send their Letter of Non-Repudiation.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed conflicting business rules regarding Comparability Protocol questions on Red Blood Cells, Platelets, Plasma, and Fresh Frozen Plasma product screens in Core Questions template.
  • Fixed conflicting business rules in Computer-Assisted Interactive Donor History section in Processes template so that data entered in Web-Based CASI SOP section is not cleared after being entered.
  • Minor content updates and bug fixes.
Version 1.75.01 - Released October 7, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
  • Released CDER’s eSubmitter templates for SPL Drug Registration and Listing.
  • Released CDER’s eSubmitter templates for ICSR Drug Adverse Event Reporting.
  • Added new folder designation under Preferences to differentiate between standard outputs (e.g., submission and missing data report) and the submission package to minimize confusion regarding which files to submit.
Fixes
  • None.
Version 1.74.01 - Released September 7, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Revised the CBER Core Question template to fix a contact question report output issue.
  • Revised the hint text of the Type of Submission question in the 356h template.
  • Fixed an issue here international characters were causing loss of data in the contact and address books.
  • Fixed an issue where sometimes Excel data failed to import.
  • Fixed an issue where sometimes child data of a relationship was not properly being deleted when the parent was deleted.
Version 1.73.01 - Released August 5, 2011
Enhancements
  • CBER Templates updated to reflect transition from Pilot program to live production environment:
    • Inactivated the Pilot Source Plasma template (the production BLA/Source Plasma template should be used instead going forward). However, any existing submissions in progress related to the Pilot Source Plasma template will still have until 2/8/2012 to complete their submissions.
    • Added FEI and Registration Number fields to Establishment Details node in 356h template.
    • Minor fixes and updates made in Labeling template.
  • Adjusted business rules for the "Update to a Registration Listing" when an operator's address is being updated and the operator is also the owner.
  • Added a new Tobacco Product's template to provide an ESG Transmittal Submittal Form.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue where some data was not populating correctly in the Rad Health Submittal Letters.
  • Fixed an issue where older look up table data (e.g., product code, guidance, and standards) were not being properly deleted after an update.
Version 1.72.02 - Released July 15, 2011
Enhancements
  • Added "CVM Submission #" to the Reactivation of an Original ANADA.
  • Revised hints for NADA Supplements.
  • Modified rules for JINAD and ANADA Meeting Requests to be sent to Review Division 160.
Fixes
  • None.
Version 1.72.01 - Released July 5, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.71.01 - Released June 6, 2011
Enhancements
  • Adjusted the MedWatch packaging screen by removing the option to submit by CD.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue where a required email address for a Rad Health related contact was being allowed to be submitted without a value.
  • Fixed an issue where a required telephone number for a Rad Health related establishment was being allowed to be submitted without a value.
  • Fixed an issue where the reporting date range of a Rad Health annual report was missing from the submittal letter.
Version 1.70.01 - Released May 6, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue where the memory settings under the File > Preferences were not saved.
  • Fixed an issue where a missing separator at the end of the file locations of the File > Preferences was causing an issue during packaging.
Version 1.69.01 - Released April 5, 2011
Enhancements
  • Adjusted several Rad Health templates to include the following: updated OMB expiration date, list of laser types, office addresses, and the exponent list for laser output levels.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed a list refresh issue after data was imported from an Excel spreadsheet into a tabular screen.
Version 1.68.01 - Released March 11, 2011
Enhancements
  • Released templates for CVM's Office of New Animal Drug Evaluation (ONADE) submissions.
  • BLAs for Whole Blood and Blood Components Labeling template: Added the ability to submit a Previously-Approved Label with a BLA product submission. Previously, user was forced to submit all the details and attach labels, even if labels had already been approved by the FDA.
  • Annual Report template: Changed Reporting Period from a single text field to two unique Date fields to allow for validation of dates.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Amendment template: Changed HTML Memo fields to Plain Text Memo fields to fix appearance in Submission Report output
Version 1.67.01 - Released February 11, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.66.01 - Released January 10, 2011
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.65.02 - Released December 20, 2010
Enhancements
  • Added templates for new CBER Pilot Evaluation Program for Establishments that Collect Whole Blood and Blood Components.
Fixes
  • Reduced the time required to load submission files.
Version 1.65.01 - Released December 7, 2010
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed a minor textual change to Rad Health templates.
Version 1.64.01 - Released November 5, 2010
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.63.01 - Released October 8, 2010
Enhancements
  • Added new templates in support of the Center for Veterinary Medicine (CVM) eSubmitter "Beta-Test" program.
  • Added sorting capabilities to the Open Submission dialog by clicking on the column header.
  • Began replacing the outdated HTML-based help with links to the more comprehensive user manual.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed a minor issue related to Rad Health Annual Reports.
Version 1.62.01 - Released September 21, 2010
Enhancements
  • Updated News and Alerts with information regarding adjusted device problem codes used under F10 of the 3500A MedWatch form
  • Updated product code, guidance, and standards lookup tables
Fixes
  • None.
Version 1.61.01 - Released August 5, 2010
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue resulting in an error when attempting to create a new submission from the Open Submission Dialog.
Version 1.60.01 - Released July 14, 2010
Enhancements
  • Added a memory configuration section to the preferences dialog to allow user adjustment in support of very large data submissions.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Minor updates to Rad Health templates.
Version 1.59.01 - Released June 11, 2010
Enhancements
  • Minor updates to Tobacco Templates 904a1 and 905.
  • Modified the FEI number to allow between 7 and 10 digits.
Fixes
  • Fixed the missing data report to correctly handle relationship logic (currently only used within Tobacco's 904 Template).
  • Fixed the report output to correctly handle relationship logic (currently only used within Tobacco's 904 Template).
Version 1.58.01 - Released May 7, 2010
Enhancements
  • Updated CTP's Templates to include the following:
    • Updates to the product list for the Tobacco Establishment Registration and Product Listing submission
    • Updates to the ingredient list for the Listing of Ingredients in Tobacco Products submission
Fixes
  • Fixed the check box in the Tobacco Health Documents Submission report output.
  • Fixed the telephone number field to prevent the PDF from printing with a null value when international numbers are entered along with spaces to accommodate for the field length.
Version 1.57.02 - Released April 19, 2010
Enhancements
  • Released the Health Documents submission type for CTP.
Fixes
  • None.
Version 1.57.01 - Released April 5, 2010
Enhancements
  • Added new filter option that combines all the singular options into one filter so all file types can be accessed at the same time.
  • Added a new Active indicator to the MDR code data so that all codes are available when viewing data but only Active codes are available for selection
  • Changed address for the OIVD submittal letter
Fixes
  • Fixed issue to correctly identify the zip code as missing when the establishment address question is required.
  • Fixed the issue to prevent file Names and Package Names from being saved with a period.
Version 1.56.01 - Released March 5, 2010
Enhancements
  • Updated Tobacco's Templates to include the following:
    • Added a warning message when the user changes the selection of "New Submission" to "Update".
    • Modified question on Submission Content screen.
    • Added the ingredient name as the internal identifier.
    • Included the memo field with the file attachment to allow users to provide additional information when necessary.
  • Updated the contact information for CDRH's Office of In-Vitro Diagnostic Devices.
  • Minor updates to the eMDR's Template.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.55.01 - Released February 5, 2010
Enhancements
  • Updated the Listing of Ingredients for Tobacco Products template to include minor revisions to the FDA-assigned Tobacco Product (TP) Number.
  • Updated the contact information for CDRH's Office of In-Vitro Diagnostic Devices.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.54.01 - Released January 6, 2010
Enhancements
  • Added the file description text entered for file attachment responses to the Submission Report output (PDF version).
  • Updated the OMB expiration date on the 3500A template screen footer.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed an issue where text entered in place of attaching a file was not outputting on the Submission Report (PDF version).
Version 1.53.01 - Released December 7, 2009
Enhancements
  • Updated the BLA Source Plasma templates to include minor revisions.
  • Updated the OMB expiration date on the 3500A template.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.52.01 - Released November 27, 2009
Enhancements
  • Released the Listing of Ingredients in Tobacco Products submission type for CTP.
Fixes
  • None.
Version 1.51.01 - Released November 9, 2009
Enhancements
  • Released the Tobacco Establishment Registration and Product Listing submission type for CTP.
Fixes
  • Updated FDA mailing address information for CDRH submissions.
Version 1.50.01 - Released October 5, 2009
Enhancements
  • Added a pop-up message describing the purpose of the e2579 "Temporary Copy" output form when viewing the Submission Report from the Output menu option and Packaging Wizard.
  • Added text "Not an Official Copy, Not for Submittal" on the e2579 "Temporary Copy" output form.
  • Updated the CDRH Address on the Introduction Node/Screen.
  • Minor updates to the CBER Source Plasma templates and an update to the 356h Form to identify Annual Reports when selected as the Submission Type.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.49.01 - Released September 8, 2009
Enhancements
  • Updated the BLA Source Plasma templates to include minor revisions.
  • Introduced the CBER Annual Report template.
  • Updated the CBER 356h template and business rule logic to account for the addition of the CBER Annual Report template.
  • Adjusted several FDA links within the Links tab of the Welcome page.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.48.01 - Released August 5, 2009
Enhancements
  • Enhanced the Radiological Health Annual Report template to allow for 1,000 Model entries (Part 3).
  • Updated the Question Names for the Model Family and Model Designation question(s) within the Radiological Health Annual Report Template (Part 3).
  • Updated the Address within various Radiological Health templates for eSubmissions to be sent on CD for processing by the DMC.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.47.01 - Released July 6, 2009
Enhancements
  • Enhanced the CBER templates, the 356h and 2567 output forms to incorporate FDA reference numbers so they can be linked within the Contacts and Addresses feature.
  • Adjusted several FDA links within the CBER template to reflect changes on the FDA website.
  • Updated the FDA Registration number panel to include a link for searching on Blood Establishment Registrations.
  • Enhanced the display of device problem and patient problem codes (and added the new device component code) into a hierarchial structure in the search module for section F10 of the 3500A template.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed issue with the "Display Configuration" button launching from the Help > About Menu.
Version 1.46.01 - Released June 5, 2009
Enhancements
  • Enhanced the OIVD Submission template under Section 2.0 of the OIVD Submission tab to incorporate improved business rule logic.
  • Adjusted several FDA links within the application and documentation to reflect changes in the FDA website.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.45.01 - Released May 5, 2009
Enhancements
  • Minor updates to the Source Plasma licensing template.
  • Consolidated Radiological Health Annual Reporting requirements for all product areas (except Laser Light Shows) into the General Annual Report Template.
  • Updated Intro Screen to include minor adjustments to Radiological Health contact information.
  • Updated Intro Screen to include minor adjustments to the Source Plasma pilot details.
  • The application install file has now been zipped and posted to the web. This change requires that users unzip the install after saving it to their computer from the webpage.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed minor issue with the processing of business rules within a Radiological Health template.
Version 1.44.01 - Released April 6, 2009
Enhancements
  • Updated the OIVD CLIA Categorization Request template to include several new questions regarding reason for submission.
  • Updated the Laser Radiation Safety Report to allow for multiple file attachments under the product description section (Part 3).
  • Fixed issue with the file attachment question type not allowing users to filter on file types other than PDF.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.43.01 - Released March 16, 2009
Enhancements
  • Introduced the CBER Pilot Evaluation Program, which includes the BLA/BLS submission for Source Plasma collection.
  • Updated the Intro Screen to include CBER related information and corresponding message filter.
  • Introduced the new eSubmitter logo and updated the application banner and splash screen.
  • Updated the User Manual, Quick Guide and Technical FAQ to reflect the recent changes to eSubmitter.
  • Updated various textual descriptions of menu options, tool options and mouse-over's to introduce generic FDA terminology.
  • Enhanced the File Attachment dialog to improve usability.
  • Improved the table question type to provide additional restriction crtieria during data entry.
  • Changed field lengths for various fields within the
  • Contact and Address question types.
  • Introduced the default response capability in which various questions may include a preset response.
  • The response may be enabled and editable or disabled and static.
  • Updated the radio button question type to support multi-line capabilities.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.42.01 - Released February 5, 2009
Enhancements
  • Updated product code, guidance, and standards lookup tables.
  • Minor updates to the OIVD Template(s).
Fixes
  • None.
Version 1.41.01 - Released January 5, 2009
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
Version 1.40.01 - Released December 5, 2008
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed issue where the Rad Health description was missing in the "Create Submission" dialog.
Version 1.39.01 - Released November 6, 2008
Enhancements
  • Updated table configuration and available product codes for Abbreviated Product Reports (within the Radiological Health Master Template).
  • Added new properties to Address, Contact, and Establishment question types to allow changes to field lengths, customized labels, and adjustments to required status for certain fields. These changes may appear within a template that could enforce changes to existing or previous submission data.
    • For this release, only the 3500A form is affected in regards to utilizing these new properties for the Address, Contact, and Establishment question types. Address Line 1 and Line 2 fields in sections D3, E1, F14, G1, and G2 previously allowed 50 characters. These fields in the 3500A form have been modified to limit the maximum number of characters to 30. Please note that when opening existing or previous submissions, if there are more than 30 characters in these fields, the data will be truncated to 30 characters upon entering the specific screens of the fields in question.
  • Enhanced question properties to allow default responses to be preset within a template (submission form). This feature is available for Text Field, Check Box, Combo Box, and Radio Group question types and the feature may appear within an existing submission form.
  • Added support to the copy up function within the Contact and Address books to allow the user to specify whether to add new or overwrite contacts and establishments when the name already exists.
  • Report of Assembly of a Diagnostic X-Ray System template has been updated with the following changes:
    • Master Control Room is optional when Mobile unit selected.
    • Dates of Manufacture are all optional fields.
    • Added a hint to each Date of Manufacture field to include Comments when the entry is skipped.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • Fixed issue with certain data fields not copying correctly from Establishment Address books.
  • Fixed issue where the 3500A form allowed the user to enter more characters than the database could store for the Address Line 1 and Line 2 fields in sections D3, E1, F14, G1, and G2. Reports with more than 30 characters in these fields were rejected by the system. In the 3500A form, the maximum length of these fields was modified to 30.
  • Fixed issue where the 3500A form incorrectly recognized the patient problem code for "No Patient Involvement" as 2648 instead of the correct value of 2645.
Version 1.38.01 - Released October 5, 2008
Enhancements
  • Deleted Use Environment Node and contents as well as Electromagnetic Compatibility and Interface Node and contents from the RadHealth Master Template.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
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.
Fixes
  • Added a business rule to enable the Burden to Industry node on the RadHealth Master template.
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.
Fixes
  • None.
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.
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.
Version 1.34.01
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None.
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.
Fixes
  • None.
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.
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.
Version 1.31.02
Enhancements
  • None.
     
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.
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.
     
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.
Version 1.30.01
Enhancements
  • Updated the Med Watch (3500A) template to include the following:
    1. New submission report output that is similar in structure to the standard 3500A form.
    2. New Form Code entry for organizations that have an FDA assigned Form Code.
    3. New User Facility and Importer support.
    4. Changed Report Number data entry to default to the CFN structure instead of the FEI structure.
    5. 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.
Version 1.29.01
Enhancements
  • Updated the ODE Administrative Template to include the following:
    1. New Submission Type to allow for a 510(k) and CLIA Waiver Combination submission.
    2. Enhanced the ODE Administrative Template to include a link to FDA Form #3654 Standards Data Report.
    3. Enhanced the ODE Administrative Template to include a new section for Certification of Compliance with Clinical Trials.
    4. 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.
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.
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.
Version 1.26.02
Enhancements
  • None
Fixes
  • Fixed bug related to several filter dialogs failing to be displayed.
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.
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.
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.
Fixes
  • None.
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.
Fixes
  • Updated the MedWatch form template with minor fixes to section D4.
Version 1.21.02
Enhancements
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None
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).
     
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.
Fixes
  • None
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.
Fixes
  • None
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.
Fixes
  • None
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.
Fixes
  • None
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.
Fixes
  • None
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.
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.
Fixes
  • None
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.
Fixes
  • None
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.
Fixes
  • None
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.
Fixes
  • None
Version 1.11.04
Enhancements
  • Updated various business rules and questions within the Rad Health templates.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None
Version 1.11.03
Enhancements
  • Updated various business rules and questions within the Rad Health templates.
  • Updated product code, guidance, and standards lookup tables.
Fixes
  • None
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.
Fixes
  • None
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.
Fixes
  • None
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.
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.
Fixes
  • None
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).
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.
Version 1.09.00
Enhancements
  • None
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.
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.
Fixes
  • None
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.
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.
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.
Fixes
  • Fixed business rules in the Sunlamp Product Report, OEM Report, and the Abbreviated Product Report.
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.
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.
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.
Fixes
  • Fixed an issue related to viewing old eLaser reports where picklist data was not displaying properly.
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.
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).
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.
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).
Fixes
  • Fixed issues related to foreign addresses and the contact/establishment questions and books.
Version 1.00.00 (Initial Release)