Change, Deactivate or Reactivate Listings for Medical Device Products

July, 2016

Change a Listing

Select Listing Screen

Select the listing that you wish to change. After clicking "Change Listing", details about the device listing will be displayed. Carefully review this information to verify this is the device you intended to select.

If not, you may continue to navigate through the listings or use the numeric page number options to reach a specific page of listings if multiple are present.

You may also filter Listings by Listing Number. This can be done by entering a Listing Number into the system and selecting the Filter button.

Note: Only one Listing Number may be filtered at a time.

Select Facilities Screen

If you identify the listing as a Combination Product, you must identify the types of combination products that this device is a part of. If the listing has already been identified as a Combination Product, then you may update the types of combination products that are already selected with your listing.

Note: You can always change your combination products to non-combination products by following the same steps and simply checking or unchecking the combination product checkbox.

Combination Products

Select any and all activities related to this device for each of the facilities added.
Enter any proprietary names that the device is distributed under for each of the facilities.

Select Product Activities

This screen allows you to list activities related to each of the products associated with the facility. Check all activities that are performed at this facility and click "Next".

Note: You must select at least one activity for each product.

Select Activities for Listing(s)

Enter Proprietary Name(s)

Each listing must have at least one proprietary name or brand name that your product is marketed under. Unless you are participating in our pilot labeling submittal program, you can skip the section marked "Labeling Information - Pilot Program Participants Only".

Enter Proprietary Name(s)

i. Enter the proprietary name in the large box.

ii. If disclosure of this device proprietary (brand) name would reveal a trade secret or confidential information, check the box below the 'Proprietary Name' field. This will prevent the name from appearing on the public FDA website.

iii. Check the box, if the device is U.S goods returned or used equipment being imported to U.S.

iv. Check the box, if the product is no longer being produced but will remain in the distribution chain, and provide date until when the product will remain in the distribution chain.

v. If you are participating in the pilot program, please provide the Intended Use by selecting a value for the question 'This device is labeled for use', and enter the Unique Device Identifier for the proprietary name in the section of the screen entitled "Labeling Information". You can skip this step if you are not participating in the pilot labeling submittal program.

vi. Click on "Add Proprietary Name".

Repeat these steps until all the proprietary names have been added. If you wish to add all of the proprietary names at the same time, you can upload the proprietary names using an Excel spreadsheet as described in the lower section of this screen entitled "Upload Proprietary Names Using Spreadsheet".

To make any changes to a proprietary name, click on Edit in the last column on the right of the proprietary name shown in the table below (if you have not previously entered names for this listing, this table will not appear).

To remove a proprietary name, check the box next to the proprietary name and click "Remove Selected Proprietary Name(s)". If you want to remove more than one proprietary name, check the box next to each proprietary name that you want to remove and click on "Remove Selected Proprietary Name(s)".

When you are finished, click "Next" to go to the next screen.

Add Labels Summary

The Add Labels Summary page shall display when you continue from the Enter Proprietary Name(s) page and at least one proprietary name has a value selected for the question 'Is this device labeled for use'.

The proprietary names for listings that require label upload shall be displayed on this page. You can add and remove labels for each proprietary name by selecting the icon in the "Actions" column.

Add Labels Summary:

Add Labels

The Add Labels page shall display when you select "Add/Remove Labels" for a proprietary name on the Add Labels Summary page.

Add Labels:

For each file that you upload, please provide the following information:

a. Type of Labeling Material (This is a required field when a label file is uploaded)
b. Date label was First Disseminated (This is an optional field)
c. Date label was Removed from Market (This is an optional field)

You can upload labels for each proprietary name. The accepted file types are pdf and spl. Each upload file is limited to 50MB. Please Note: If the upload time exceeds 2 minutes, the system will timeout without saving your file.

Browse for the label, select a file and click "Add Label". Repeat these steps until all label files have been added.

Add Labels Summary page after Labels are uploaded

After you have uploaded label(s), the label filenames shall be displayed beside their respective proprietary names on the Add labels Summary page.

Add Labels Summary

Once you have completed uploading label files, click "Return to Add Proprietary Name".

Confirmation

Details about the listing change are displayed, including all facilities associated with the listing, all activities performed at the facilities as they relate to the device, and all proprietary names associated with the facility.

Verify that the information is as you intended before clicking the box by the Certification Statement and "Submit" to complete the change process. A confirmation of your changes will be displayed.

Confirmation Screen

Note: If this is a listing for a foreign facility, the United States Federal Bioterrorism Act of 2002 requires that the U.S. importer for each of the devices exported to the U.S. be provided. Provide at least one search criteria to find an Importer. The steps may be taken as follows:

Initial Importer Search Options Screen

Initial Importer Search Results Screen

 

Deactivate a Listing

While it is not possible to cancel a medical device listing, you may deactivate the listing so that it is no longer associated with any of the facilities under your account.

Select the listing that you wish to deactivate.

Select Listing Screen

Carefully review the information to verify that this is the device that you intended to deactivate. Please remember to check the Certification Statement check box.

Listing Review and Certification

A confirmation of the listing deactivation will be displayed.
You can reactivate the listing and re-associate it with any of the facilities under your account at any time.

Confirmation Screen

Reactivate a Listing

Select Listing Screen

Select the listing that you wish to reactivate. After clicking "Reactivate Selected Listing", details about the device listing will be displayed. Carefully review this information to verify this is the device you intended to select.

Scroll down the page and select facilities that you want to associate with this device (i.e., facilities where the device is processed in some way) or deselect facilities that no longer process the device.

Select Facilities Screen

If you identify the listing as a Combination Product, you must identify the types of combination products that this device is a part of. If the listing has already been identified as a Combination Product, then you may update the types of combination products that are already selected with your listing.

Note: You can always change your combination products to non-combination products by following the same steps and simply checking or unchecking the combination product checkbox.

Combination Products

Select any and all activities related to this device for each of the facilities added.
Enter any proprietary names that the device is distributed under for each of the facilities.

Select Product Activities

This screen allows you to list activities related to each of the products associated with the facility. Check all activities that are performed at this facility and click Continue
Note: You must select at least one activity for each product.

Select Activities for Listing(s)

Enter Proprietary Name(s)

Each listing must have at least one proprietary name or brand name that your product is marketed under. Unless you are participating in our pilot labeling submittal program, you can skip the section marked "Labeling Information".

Enter Proprietary Name(s)

i. Enter the proprietary name in the large box.

ii. If disclosure of this device proprietary (brand) name would reveal a trade secret or confidential information, check the box below the 'Proprietary Name' field. This will prevent the name from appearing on the public FDA website.

iii. Check the box, if the device is U.S goods returned or used equipment being imported to U.S.

iv. Check the box, if the product is no longer being produced but will remain in the distribution chain, and provide date until when the product will remain in the distribution chain.

v. If you are participating in the pilot program, please provide the Intended Use by selecting a value for the question 'This device is labeled for use', and enter the Unique Device Identifier for the proprietary name in the section of the screen entitled "Labeling Information". You can skip this step if you are not participating in the pilot labeling submittal program.

vi. Click on "Add Proprietary Name".

Repeat these steps until all the proprietary names have been added. If you wish to add all of the proprietary names at the same time, you can upload the proprietary names using an Excel spreadsheet as described in the lower section of this screen entitled "Upload Proprietary Names Using Spreadsheet".

To make any changes to a proprietary name, click on Edit in the last column on the right of the proprietary name shown in the table below (if you have not previously entered names for this listing, this table will not appear).

To remove a proprietary name, check the box next to the proprietary name and click "Remove Selected Proprietary Name(s)". If you want to remove more than one proprietary name, check the box next to each proprietary name that you want to remove and click on "Remove Selected Proprietary Name(s)".

When you are finished, click Continue to go to the next screen.

Add Labels Summary

The Add Labels Summary page shall display when you continue from the Enter Proprietary Name(s) page and at least one proprietary name has a value selected for the question 'Is this device labeled for use'.

The proprietary names for listings that require label upload shall be displayed on this page. You can add and remove labels for each proprietary name by selecting the icon in the "Actions" column.

Add Labels Summary

Add Labels

The Add Labels page shall display when you select "Add/Remove Labels" for a proprietary name on the Add Labels Summary page.

Add Labels

For each file that you upload, please provide the following information:

a. Type of Labeling Material (This is a required field when a label file is uploaded)
b. Date label was First Disseminated (This is an optional field)
c. Date label was Removed from Market (This is an optional field)

You can upload labels for each proprietary name. The accepted file types are pdf and spl. Each upload file is limited to 50MB. Please Note: If the upload time exceeds 2 minutes, the system will timeout without saving your file

Browse for the label, select a file and click "Add Label". Repeat these steps until all label files have been added.

Add Labels Summary page after Labels are uploaded

After you have uploaded label(s), the label filenames shall be displayed beside their respective proprietary names on the Add labels Summary page.

Add Labels Summary

Once you have completed uploading label files, click "Return to Add Proprietary Name".

Listing Review and Certification Screen

• Review all your listings in the "Listings Summary" table
• To Edit, Remove or View the product from the listing summary - Select icon to edit listing, icon to remove listing, icon to view listing proprietary
• Add a new product - Add more listings by clicking "Add New Product".
• Go to Owner/Operator Product List - Add a product associated with your account that was listed in the Owner/Operator Product List Screen.
• Finished Identifying Products - Click Next button once you are satisfied that the appropriate products are associated with the facility and that all activities and proprietary names are accurate and complete.

The system will prompt for the Payment Identification Number and Payment Confirmation Number (PIN/PCN).

A confirmation of the reactivated listing will be displayed.

PIN/PCN Entry Screen

Confirmation Screen