The electronic Human Cell and Tissue Establishment Registration System (eHCTERS) web site is upgraded continuously. CBER reviews the site periodically to ensure reliable access for data entry and retrieval of saved data. To facilitate user understanding of recent changes, upgrades made to the system are outlined below.
Version 02.13.03 Release Information - Release Date 04/11/2024
- eHCTERS
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Modification to mitigate CSRF(Cross-Site Request Forgery) security vulnerability
Version 02.13.02 Release Information - Release Date 10/13/2023
- eHCTERS
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Modifications made to add link to the OMB Burden Statement in Footer
Version 02.13.01 Release Information - Release Date 07/23/2021
- eHCTERS
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Modifications made to enhance system stability
- eHCTERS Public Query
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Modifications made to enhance system stability
Version 02.13.00 Release Information - Release Date 11/20/2020
- eHCTERS
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Updated application to utilize the Geopolitical Entities, Names, and Codes (GENC) data standard.
- eHCTERS Public Query
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Updated application to utilize the Geopolitical Entities, Names, and Codes (GENC) data standard.
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Updated business rules for calculation of Last Annual Registration Year on the Establishment Details screen.
Version 02.12.00 Release Information - Release Date 05/08/2020
- eHCTERS
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Modifications made to enhance system security
- eHCTERS Public Query
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Modifications made to enhance system security
Version 02.11.00 Release Information - Release Date 10/25/2019
- eHCTERS
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Increased the character limit of the Proprietary Name field to allow for the entry of up to 1000 characters of Proprietary Name information per HCT/P
- eHCTERS Public Query
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Increased the character limit of the Proprietary Name field to allow for the display of up to 1000 characters of Proprietary Name information per HCT/P
Version 02.10.00 Release Information - Release Date 11/09/2018
- eHCTERS
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Removed references to Form FDA 3356 throughout the application
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Added functionality to associate multiple U.S. Agents for an establishment located outside the United States (U.S.)
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Added Importer screen to allow entry of information for all importers known to a non-U.S. establishment
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Updated the available list of Types of HCT/Ps on the HCT/P Listing screen and removed the Additional HCT/P Listing Information screen
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Removed two designations from the HCT/P Listing Information screen because eHCTERS is no longer used for registering these products: “HCT/P's Regulated as Medical Devices” and “HCT/P's Regulated as Drugs or Biological Drugs”
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Added capability to enter the Date of Discontinuance and Date of Resumption on the HCT/P Listing Information screen
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Replaced the “Test” function with “Donor Testing” on the Function Information screen
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Updated the list of Types of HCT/Ps and the donor types on the Donor Information screen
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Replaced the fillable form with contact information of tissue registration mailbox and deleted fax information on the Human Cell and Tissue Establishment Registration (HCTERS) – Contact page
- eHCTERS Public Query
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Updated selections for Establishment Function and the Product list of values on the Enter Query Criteria screen
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Updated the list of Types of HCT/Ps displayed in the Establishment Functions and Establishment HCT/P Listing sections of the Establishment Details screen
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Removed the “HCT/P's Regulated as Medical Devices” and “HCT/P's Regulated as Drugs or Biological Drugs” columns in the HCT/P Listing section
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Updated the list of Types of HCT/Ps and the donor types in the Donor Information section
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Replaced the fillable form with contact information of tissue registration mailbox and deleted fax information on the Human Cell and Tissue Establishment Registration (HCTERS) – Contact page
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Added the Print Date on the Establishment Details screen
Version 02.08.00 Release Information - Release Date 11/04/2016
- eHCTERS
- Modified the eHCTERS Activity Selection page to display the date and time of the last session where the user accessed the eHCTERS Registration Module.
- Incorporated usability updates to the eHCTERS Activity Selection page.
- Removed obsolete header and footer links from the eHCTERS Registration Module.
- eHCTERS Public Query
- Removed obsolete header and footer links from the eHCTERS Public Query.
- Incorporated system improvements to the eHCTERS Public Query – Enter Query Criteria page when searching on the “Country” field.
- Incorporated usability updates to the eHCTERS Public Query – Query Results page.
- Modified the eHCTERS Public Query – Query Results page to sort search results for non-US establishments by State (Province) name instead of State (Province) code when sorting the results by State / Zip.
Version 2.07.00 Release Information - Release Date 04/10/2015
- Added the Possible Establishment Matches Found page to notify the user entering an initial registration if the establishment name and address are similar to existing registrations in the database. The page displays possible establishment matches to help the user determine whether to complete the initial registration or edit an existing registration.
- Corrected the Pending Submissions page to display submitted reports for only 7 days.
Version 2.06.00 Release Information - Release Date 08/13/2014
- Modifications made to adjust data entry restrictions.
Version 2.05.00 Release Information - Release Date 06/27/2014
- Modifications made to enhance system security.
Version 2.4.0 Release Information - Release Date 5/02/2014
- eHCTERS - Activity Selection
- Save unsubmitted data into archive table 30 days after they were entered
- Delete unsubmitted data from archive tables 180 days after they were entered.
- Email RO if data are entered in eHCTERS but have not yet submitted after 20 days
- Maintain the values for the FDA Form, OMB number, and form expiration date in the database
- Public Query
- eHCTERS Public Query - Resulting firms shall have all selected HCT/P AND Functions
- eHCTERS Public Query 508 Compliance – Enter Query Criteria
- Contact eHCTERS Technical Support
- Required use of CAPTCHA on public facing email web forms.
Version 2.2.0 Release Information - Release Date 10/24/2008
- Function Information Screen
- The HCT/P Type called 'No HCT/P specified' has been removed.
- Instructions ‘Function Information Screen’ section
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The instructions section “Function Information Screen” text will be modified to remove the following sentence: “No HCT/P Specified: Donor testing establishments that do not know what HCT/P has been recovered from the donor should indicate (with a check) the test function on the first line – “No HCT/P Specified.” This option is displayed for selection only when no HCT/Ps have X or R values on the HCT/P Listing Information screen.”
- HCT/P Listing Information Screen
- Each registration submission must have at least on one HCT/P entered on this screen.
- The current HCT/P named Somatic Cells has been renamed to Somatic Cell Therapy Products.
- Additional HCT/P Listing Information Screen
- 'Other' products must now be selected from the list of approved other products.
- Public Query
- The current HCT/P named Somatic Cells has been renamed to Somatic Cell Therapy Products.
- The HCT/P Type called 'No HCT/P specified' has been removed from the Establishment Details page.
Version 2.1.0 Release Information - Release Date 01/18/2008
- eHCTERS - Initial / Edit Establishment Registration Information Screen
- Modified the “Other FDA Registration” check boxes so the database would correctly capture un-checked values.
- Public Query Update
- The Establishment Registration Public Query was modified to align with changes made on the Form FDA 3356.
Version 2.0.0 Release Information - Release Date 11/15/2007
eHCTERS Electronic Form 3356 (Link to Form 3356)
- Establishment Address Information Screen
- A new field was added to capture whether the facility is a 'Satellite Recovery Establishment'.
- A new field was added to capture ‘Manufacturing Establishment FEI Number’. This field is required when a check is placed in the 'Satellite Recovery Establishment' checkbox.
- A field was added to capture whether a facility performs 'Testing for Micro-Organisms only'.
- HCT/P Listing Information and Additional HCT/P Information Screens
- These screens now allow HCT/Ps to be distinctly identified as ‘Regulated as Medical Devices’ or ‘Regulated as Drugs or Biological Drugs’. If applicable, multiple regulations can be selected for a single HCT/P.
- Function Information Screen
- The Function Information screen has been modified to allow selection of functions performed by the registered establishment in conjunction with the type of HCT/P that the registered establishment manufactures. Please note that ‘Test’ and ‘Screen’ refer to the donor, not the HCT/P.
- To enable Function entry (via checkbox) an HCT/P must first have a regulation selected on the HCT/P Listing Information screen.
- Donor testing establishments that do not know what HCT/P has been recovered from the donor can now select the ‘Test’ function on the first line – “No HCT/P Specified.” To display this option, ensure that no X or R values are listed in the regulation columns of the HCT/P Listing Information screen.
- Donor Information Screen
- A new screen has been added to capture Donor Information for select listed HCT/Ps.
- When listing Embryo, Oocyte, and Semen on your registration, indicate whether the HCT/Ps are from SIP, Directed, and/or Anonymous.
- When listing Peripheral Blood Stem Cells, Somatic Cells, and Umbilical Cord Blood Stem Cells on your registration, indicate whether the HCT/Ps are Autologous, Family Related, and/or Allogeneic.
- Registration Preview and Submitted Registration Screens
- The Registration Preview screen (accessed using the ‘Report’ button) and the Submitted Registration screen (display after submitting) have been updated to include the new and updated information fields implemented in this version of eHCTERS.
- Registration Error Screen
- New validations were added to notify users upon submittal when required Function and Donor Information has not been entered. The system provides navigation to each screen where user entries can be corrected.
- Navigation Changes
- ‘Donor’ was added to the navigation bar to facilitate access to the new screen ‘Donor Information’.
- ‘HCT/P Listing' was moved to appear before 'Function' to account for a change in page order.
- Next and previous button navigation changes were made to various screens to account for page order changes and the new Donor Information screen.
Version 1.8.0 Release Information - Release Date 05/04/2007
eHCTERS Electronic Form 3356 (Link to Form 3356)
/ eHCTERS Public Query (Link to Public Query)
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Require RO Email address confirmation prior to submitting
The system now requires each user to confirm the reporting official email address prior to accepting their registration submission. Confirmation will be performed on the RO Signature page and requires the user to correctly re-enter the Reporting Official Email Address. The entered E-Mail Address must match the Reporting Official Email Address entered on the registration for the submission to be accepted.
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Allow Initial Registrants to see if they are already registered
On the Activity Selection screen - When a user presses the initial registration radio button, the system will display a new page called “Initial Registration Selection” to help confirm that initial registration is really required. The page will prompt the user to confirm that initial registration is required, allow the user to launch the HCTERS Public Query to see if they are already registered or check their registration status, or return to the Activity Selection screen.
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Prohibit Registration edits prior to Annual Registration
Code has been added to the eHCTERS system to automatically prohibit Change in Information and Annual Registration submissions immediately prior to the Annual Registration period. Users may not create these types of submissions from November 1st through November 14th. During this period, only Initial Registrations and submissions that In-Activate an establishment registration will be allowed. Users may begin submitting Annual Registrations on November 15th.
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Public Query – Search for Establishments by Product
The Tissue Establishment Registration Public Query - Enter Query Criteria page now allows the user to search for establishments by “Product”. The user may select one product or hold down the CTRL key on their key board and select multiple products. The query will return establishments that report one or more of the selected products on their Tissue Establishment Registration (Form FDA 3356).
Version 1.7.0 Release Information - Release Date 07/31/2006
eHCTERS Electronic Form 3356 (Link to Form 3356)
/ eHCTERS Public Query (Link to Public Query)
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The system was modified to allow compatibility with upgraded development software. No functional changes were made in this release.
Version 1.6.0 Release Information – Release Date 05/05/2006
eHCTERS Electronic Form 3356 (Link to Form 3356)
/ eHCTERS Public Query (Link to Public Query)
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An administrative query was added. No functional changes were made to the electronic Form 3356 or to the public query in this release.
Version 1.5.0 Release Information - Release Date 03/11/2006
eHCTERS Electronic Form 3356 (Link to Form 3356)
/ eHCTERS Public Query (Link to Public Query)
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The system was modified to allow compatibility with upgraded development software. No functional changes were made in this release.
Version 1.4.0 Release Information - Release Date 06/24/2005
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Establishment Registration Information page (Registration tab) - For Annual Registration and Change in Information submissions, if your establishment is already registered with FDA as a Blood, Medical Device, or Drug establishment you may now provide your FEI number.
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Preview Your Information page (Report tab) - Text was added to clearly state that the registration has not been submitted and the “Submit To FDA” button must be pressed to continue.
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Submissions Pending page - An error that would occur when trying to create a new 3356 submission from this page was corrected.
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Submissions Pending page - The “Created By” value that displays next to all submission will now be the user’s first and last name.
Version 1.3.0 Release Information - Release Date 11/26/2004
Version 1.2.1 Release Information - Release Date 09/01/2004
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The FORM FDA - 3356 expiration date is changed to July 31, 2007.
Version 1.2.0 Release Information - Release Date 04/16/2004
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The application follows the FDA standards. The look and feel is same as other FDA applications. Also the 'Contact CBER' link has been changed to 'Contact eHCTERS Technical Support'.
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The existing user establishments drop down list for the particular user is sorted by the FEI numbers.
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The validated date has the validation to check if the date is in 'MM/DD/YYYY' format.
Version 1.1.0 Release Information - Release Date 09/05/2003
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State and Zip Code are now required where country is United States.
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Initial registrations are no longer prompted to enter their Tissue FEI number.
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Wording on Reporting Official Signature page has been updated.
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Where addresses line 2, 3, or 4 are entered, line 1 will now be required.
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Establishments located in U.S. territories are not required to enter U.S. Agent information.
Version 1.0.0 Initial Release - Release Date 08/08/2003
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Initial release of Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).
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