July, 2016
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.
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:
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:
Product View Screen (Initial screen)
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
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:
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
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 have the option 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. 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
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.
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 'Is this device labeled for use', and
enter the Unique Device Identifier for the proprietary name in the section of the
screen entitled "Labeling Information - Pilot Program Participants
Only". 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" button to go to the next screen.
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
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.
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".
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.
Device Listings Screen
This screen lists all information that you entered during this registration process, including:
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
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
Carefully read the instructions in this confirmation and print a copy for your records. This page contains the following important information:
Confirmation Screen