Transfer Ownership of Devices and Facilities

May, 2025

Enter Facility Registration Number

Enter the Registration Number of the facility you purchased in the field and click "Next".
If a registration number exists, but you do not know it, the screen will provide a link to the FDA Search Registration Database site where you can search for the Registration number.

Registration Number Input Screen

Once you have entered the registration number and clicked "Next", details about this facility will be displayed.

Carefully review information on this screen to confirm that you are registering the correct facility.

If the information displayed is for the correct facility, select "Yes" to proceed with the registration.

Facility Details Screen

If the information displayed is not for the correct facility, select "No" and you will be returned to the previous screen where you can try entering a different registration number or search for the correct number.

Initial Importer Question (For U.S. Facility Registrations Only)

Please select "Yes" or "No" to the question of whether your facility imports medical devices to the United States.

Initial Importer Question Screen

If your facility does not import medical devices to the United States, choose "No". When you click "Next" you will be navigated to the "Identify Facility's Products" screen.

If your facility does import medical devices to the United States, choose "Yes" and an additional menu will appear to select activities for listings as shown above:

• Select all activities that are performed at this facility and click "Next" at the bottom of the screen.
• If none of the listed activities are performed at the facility, select "Next".

Identify Facility's Products

Note: This section is only applicable if you are not an initial importer or if you did not select any activity under the initial importer question.

The following options are available:

1. Add Previously Associated Products
2. Adding New Products Not Previously Associated with Your Account

Product View Screen (Initial screen)

Add Previously Associated Products

The system will display any products that have previously been added to the registration. Please select any and all products that can be added to the current facility and click on the "Add Selected Products to this Facility" button to proceed to the next screen.

Product Activity List

 

Adding New Products Not Previously Associated with Your Account

If you need to add new products not previously associated with your account (and not listed on the screen below), click "Add New Product" at the bottom of the page. If applicable, you may also need to have the appropriate premarket submission number available.

Facility Product List

Enter Product Number screen will provide an option to enter the Premarket Submission Number if applicable or enter one of the following:

• Premarket Notification (510(k)) number
• De Novo (DEN) number
• Premarket Application (PMA) number
• Product Development Protocol (PDP) number
• Humanitarian Device Exemption (HDE) number
• Investigational New Drug (IND) number
• New Drug Application (NDA) number
• An IVD offered as an LDT and do not have a premarket submission number because under the phaseout policy described in the preamble to the LDT Final Rule, FDA does not expect compliance with premarket review requirements until stage 4 or 5 of the phaseout policy, or because the IVD falls within a targeted enforcement discretion policy described in the preamble to the final rule.

If you believe the product you are listing falls under enforcement discretion, preamendment or import for export, please contact the CDRH Registration and Listing Helpdesk at reglist@cdrh.fda.gov

If you believe your device is exempt from FDA premarket notification requirements leave the Premarket Submission Number blank.

If your device is part of a combination product that includes a drug or biologic, please check the Combination Product checkbox and then click "Next".

Note: If you do not have a Premarket Submission Number you may click "Next", after indicating whether or not the product is for foreign export, as shown in the screen below:

Enter a Premarket Submission Number or Answer Exporter Question Screen

Adding Exempt Products

The following screen will display all products codes from which you can select the appropriate item. Because the listing of product codes can be quite long, you may chose to use the "Filter" option at the top of the screen to shorten your search.

Type in a word or words to describe the device, select the "filter" option and the filter will return a list of product/device names that best match the word entered. If you already know the appropriate product code for your device, enter the code in the box, and then select the "filter" option.

After selecting a product code, please click "Next" to select activities for listing (as displayed in the next section).

Search Filter Option

Select Product Activities

Note: These screens appear for all exempt and non-exempt products.

Domestic and Foreign Registrations: 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".

Select Activities for Listing(s)

This screen allows you to list activities related to each of the products associated with the facility. Check all activities that apply.

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

Add Proprietary Name(s)

Each listing must have at least one proprietary name or brand name that your product is marketed under.

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.

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" button to go to the next screen.

Review Added Listings

Here you may review newly added device listings associated with the facility you are registering. Carefully review the activities associated with the product and all associated proprietary names.

• 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 names
• 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

Device Listings Screen

Review Registration Information

This screen lists all information that you entered during this registration process, including:

• Facility information
• Buyer's Owner/Operator and Official Correspondent information
• Device listing information
• Imported products and Manufacturer's information

You may edit device information by clicking the "Edit" button over the device listing table on the screen.

When satisfied that the registration information is accurate and complete, check the box by the Certification Statement and click "Next".

Review Information

PIN/PCN

In the next screen you will be prompted to enter your valid Payment Identification Number (PIN) and Payment Confirmation Number (PCN) before completing the registration process.

Note: You must have a separate PCN for each registration shown. If you have not yet paid your annual registration user fee, you must visit the FDA User Fee website and pay for each registered facility prior to completing registration. If you have paid for your registration(s) and do not have your PIN and PCN, you can display your numbers by visiting the FDA User Fee website.

Once valid numbers have been entered, please click "Submit".

PIN/PCN Entry Screen

Registration Confirmation

Carefully read the instructions in this confirmation and print a copy for your records. This page contains the following important information:

1. The date that your registration expires
2. All documented facility registration information that you entered during this registration session
3. The fee amount

Confirmation Screen