Training and Continuing Education
Presentation: Device Establishment Registration & Listing
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Hello, my name is Joseph Tartal and I am the Postmarket and Consumer Branch Chief in the Division of Small Manufacturers, International and Consumer Assistance, at the Food and Drug Administration’s Center for Devices and Radiological Health. In this presentation I will provide you with the basic information needed to fulfill the FDA requirements for medical device registration and listing, based on requirements and changes enacted with the legislation of 2012.
In this module we will cover the following topics:
- First, the regulatory requirements involved with registration and listing;
- Second, the medical device establishment types and who must register and list
- Then when to register and list, including steps to register and list
- Next, we will review registration and listing information and the different FURLS account types and establishment account uses.
- And finally, we’ll cover the user fees for registration and listing.
I will first discuss the regulatory requirements for registration and listing as it has evolved over the course of medical device regulatory history.
The requirements of registration and listing were first provided in Section 510 of the Food Drug and Cosmetic Act which was enacted in 1976 and subsequently amended. This law requires medical device establishments to register their location and list the medical devices manufactured, prepared, propagated, compounded, assembled or processed at those establishments.
In September 2007, the FD&C Act was modified by the Food Drug Administration Amendments Act, or FDAAA, which mandated the use of an electronic registration and listing system, changed the times for annual registration and listing renewal and introduced the annual registration user fee for many establishments.
The law was further changed in July 2012 by the Food and Drug Administration Safety and Innovation Act, FDASIA. It mandated that all registered establishment types pay the annual registration user fee. Title 21 of the Code of Federal Regulation, CFR Part 807, was revised in August 2012 to reflect the laws in the 2002 bioterrorism act, FDAAA, FDASIA and explains the specific regulatory registration and listing requirements for medical device establishments.
The law and regulation also includes requirements for initial importers who bring medical devices into the United States. This information is utilized in many ways, such as for communication and inspection, and aids FDA in performing its mission to protect and promote the public health. Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products per 21 CFR 807.39.
The regulation is separated into several sections, Definitions, Procedures for Device Establishments, Procedures for Foreign Device Establishments and Exemptions. These sections will be further detailed in the following slides.
Next I will tell you who is required to register and list. All domestic establishments and foreign establishments who market and distribute a medical device in the United States should review this information
The first question that you must answer is do I have to register? Only establishments that are required to register should do so. These are the following domestic establishments that are required to register.
- Manufacturers and Remanufactures; manufacturers make, prepare, propagate, compound, assemble or process any article that meets the definition of device in section 201(h) of the act. Remanufacturers modify another manufacturer’s device by either changing the intended use or adding an additional feature or specification.
- Kit Assemblers; kit assemblers are establishments that place another establishments finished devices into a kit. They can not modify the devices or change their intended use. Kit Assemblers may register as manufacturers or specification developers depending on what activity the establishment is performing.
- Repackagers and Relabelers; repackagers and relabelers take another manufacturers device and place them in their own packaging or affix their own label. They can not modify the device or change the intended use. Private label establishments are required to meet all the labeling provisions in part 21 of the CFR including parts 801 and 809.10.
- Contract Manufacturers and Contract Sterilizers; these establishments either manufacturer a finished device for another establishment or sterilize a finished device for another establishment.
- Specification Developers; specification developers own and are ultimately responsible for the finished device they put on the market but have contract manufacturers manufacturer the finished device.
- Reprocessors of Single Use Devices; reprocessors modify single use devices for more then one use and thereby take responsibility for the device.
- Complaint Handlers; establishments that maintain complaint files as required under 21 CFR 820.198.
- Initial Importers also known as Initial Distributors are required to register. Initial importers are anyone who further markets a device from a foreign manufacturer or foreign exporter to the persons who makes final sale to the end user or consumer.
Note, Domestic Distributors, those that distribute devices only from manufacturers in the United States do not register.
For a complete list of domestic establishments that are required to register, please visit the “Who Must Register and List” page posted on the FDA website.
Next are the foreign establishments that are required to register. These are Manufacturers/Remanufactures, Kit Assemblers, Repackagers/Relabelers, Contract Manufacturers and Contract Sterilizers, Specification Developers, Reprocessors of Single Use Devices, Complaint Handlers and…
- Foreign Exporters; those who export or offer for export to the United States, a device manufactured, prepared, propagated, compounded, or processed in a foreign country, including devices originally manufactured in the U.S. . A foreign exporter must have an establishment address outside the U.S.
- Private Label Distributors – those who export a product manufactured and owned by another party under their own name under a private label agreement.
Please visit the “Who Must Register and List” page on the FDA website for a complete list of foreign establishments that are required to register.
Additionally, all of this information is summarized in the following chart.
Some entities are exempt from the registration and listing requirements. These exemptions are as follows:
Component manufacturers, that is, those entities who provide raw materials and/or components used in the manufacture or assembly of a device. Manufacturers of devices used solely for veterinary purposes. Veterinary use only devices are regulated by FDA’s Center for Veterinary Medicine.
Licensed practitioners who manufacture or otherwise alter devices solely for use in their practice. Note that this exemption is void if the practitioner distributes their device to other practitioners.
Retail establishments who provide the device directly to end users. This includes entities such as pharmacies and surgical supply outlets. Note that these retail establishments receiving devices from foreign establishments should make sure that their shipments are properly labeled.
And finally, Manufacturers of devices properly labeled and used solely in research, teaching, or analysis and are not introduced into commercial distribution.
All of these above categories of establishments are exempt from the registration and listing requirements.
Please see the regulation, 21 CFR 807 Subpart D, for a complete list of establishments that are exempt from the registration and listing requirements.
Next we’ll review some of the specific details and information involved with registration and listing.
So when is an establishment required to register and list? This depends on whether this is an initial registration or annual registration.
For an initial, or first-time, registration, this depends on what type of establishment you are.
If you are a domestic establishment, you must register and list within 30 days of putting your device into commercial distribution.
If you are a foreign establishment, you must register and list prior to exporting your device to the U.S. for the first time.
If you are an initial importer, you must register your establishment prior to importing your device into the United States for the first time. You do not list the device. However, you must identify the manufacturer of each device imported.
Note that failure by the foreign establishment to register and list, or the importer to register could result in the shipment being detained and held by FDA at the port of entry, in conjunction with the Customs and Border Patrol.
Please note Registration is not required to submit an Investigational Device Exemption, Premarket 510(k) Notification or Premarket Approval.
After the initial registration is complete, establishments are then required to review their registration and listing information annually. During the annual review, establishments must make any applicable changes to their registration and certify that their registration information is complete and accurate. This review must be done annually and completed between October first and December thirty first of each calendar year.
Establishments may update their information at any time. If an establishment knows that it will completely discontinue marketing and distributing their devices, then the FDA recommends that they deactivate their registration. This can also be done at anytime.
Next I will review the steps involved with registration. Establishments meet the registration requirements by providing the following information in the following order:
First, you must pay the annual registration fee. You cannot begin the registration process until the fee has been received and credited, more on the fee and payment at the end of the module.
Next, register the establishment in the FDA Unified Registration and Listing Systems or FURLS. Then select the device registration and listing module or DRLM and register your establishment. In a few slides I will provide more information on FURLS.
Third, provide information about the establishment, owner operator and official correspondent such as name, address, phone number and email. Later, I will define who are the owner operator and official correspondent.
Fourth, create at least one listing during initial registration. Note that initial importers cannot do this step. For devices that require a premarket submission, you can not do this step until the device can be legally marketed as you will need information from the clearance or approval letter in order to list. You may proceed directly with this step if the device is exempt.
For information to help determine if your device is exempt from pre-market submission requirements please review the FDA website. Specifically device advice, classify your device, sections on class I and class II exemptions.
Fifth, identify all proprietary names under which the product is marketed in the U.S. You may mark the proprietary name as confidential so that the name will not be displayed in our public registration and listing database.
The remaining steps now depend on whether you are a foreign establishment or initial importer.
If you are a foreign establishment, then you must identify all persons you know who import or who offer to import your product into the United States. You must also identify a U.S. agent.
Initial importers are required to identify the manufacturers of the products they import. This can be done by providing the foreign establishment’s name, address, registration number or device listing number.
The U.S. agent assists the FDA in communicating with the foreign establishment and has no direct regulatory responsibility for registration and listing. The agent may be given authority by the foreign establishment to act as the official correspondent and to receive official information or documents, which is particularly useful in cases where the FDA is not able to directly communicate with the foreign establishment. The agent may also serve to respond to questions about the products being imported or offered for import.
Now U.S. agents must reside or have a place of business in the U.S. and they cannot have a Post Office box for an address. Also, a U.S. Agent has no responsibility to report adverse events or submit premarket submissions.
If a foreign establishment changes their U.S. agent they should update that information as soon as possible in FURLS/DRLM.
All establishments who are required to register must also list their devices with FDA, except for initial importers. As noted previously, initial importers can not list.
FDA uses the listings to identify the type of devices that an establishment provides to the U.S. market.
The manufacturer or specification developer of a medical device must first list that device. Once that is done, the contract manufacturer or contract sterilizer may then list that device.
Finally, for combination products, you must identify the combination type. For example, device-biologic, device-drug, etc.
Now I will advise you on what information is needed to Register and List.
In order to list a medical device in the FURLS/DRLM, you will need to know the FDA product code and if that device is exempt from premarket submission or is pre-Amendment. Pre-Amendment devices are those devices that were in commercial distribution before May 28, 1976.
You must associate a specific activity or activities with the establishment, such as manufacturing, relabeling, etc. You must also provide all proprietary names for which the device is marketed under. Again, the proprietary names can be marked as confidential and subsequently will not be shown in the public registration and listing database.
If the device requires a premarket submission you can not list the device until you receive a clearance or approval letter from FDA for that device. The two most common pre-market submission types are the premarket notification or 510(k), whose submission number will begin with a K, and the premarket approval or PMA, whose submission number will begin with a P. The submission number must be entered by the establishment and the product codes associated with the premarket submission confirmed, and the activities performed and proprietary names must be entered as well in order to receive a listing number. Foreign establishments must also identify all importers known to them during the listing process.
Each successfully-created listing generates its own unique listing number. However all of the establishments that are under a given owner operator will share the same listing number. Note that you cannot enter or receive a new listing number for exempt devices under the same product code for the same company. Also you cannot enter or receive a new listing number for a non-exempt device already listed under a previous listing for the same company.
To register and list, you must go to the FDA’s Unified Registration and Listing System webpage. Once there, you will choose Device Registration and Listing. A link to the webpage can be found on the registration and listing website or in the registration and listing resources at the end of this presentation.
FURLS is a web-based entry system that all establishments must use unless granted a waiver from electronic registration.
Establishments may be granted a waiver from filing their registration and listing information electronically. In order to request a waiver you must submit your request in writing to the following address…
Food and Drug Administration
CDRH - Office of Compliance
Registration & Listing
10903 New Hampshire Avenue
Building 66 Room 2621
Silver Spring, MD 20993-0002
Please include a complete explanation of why you cannot submit your registration and listing information electronically. If your waiver is granted you will be notified. However you will still be responsible for paying any fee that is due.
FURLS, is the next topic of discussion.
There are two types of accounts in FURLS: the owner operator account and the official correspondent account. I will be talking more about these accounts a little bit later. Your FURLS account is different than the account used to access the user fee website and pay the user fee. The accounts have a different Account ID or Username and different Passwords.
For your FURLS account it should be noted that even though you write down your FURLS ID and password, FURLS will ask you to change this password every ninety days. In order to change your password, you will need to have your old password.
If you do not have or remember your password, you should first try the reset password function. You will need your Account ID, Secret Question and Secret Answer to use this function. If that does not work, or you do not have all the information to reset your password, you should then contact the CDRH Registration and Listing Helpdesk for assistance. Please do not create a new FURLS account if previously registered without first getting direction to do so from the CDRH Registration and Listing Helpdesk.
As noted before, there are two types of FURLS accounts.
The owner operator account is often referred to as the enterprise or primary account. The owner operator is assigned to the corporation or proprietor directly responsible for the activities of the registered establishment.
The owner operator account may create new subaccounts or official correspondent accounts. They can also create, update or deactivate registration and listings that are under all accounts.
The second type of account, the sub-account or official correspondent account is created by the owner operator and is responsible for registration and listing information for any establishment that is under their responsibility.
The official correspondent may create new registrations and listings and may make changes to existing registrations and listings assigned to them.
However they can not change any owner operator information. This may only be done by the owner operator.
This slide shows how an owner operator can create multiple official correspondent accounts. Each of which may be responsible for one or more establishments. In order to tell what type of account you have, you can log into FURLS and look for “Edit Account Profile” on the Account Management Menu. If you see the edit account profile button then you are signed in as the owner operator.
I will now discuss the user fees associated with registration and listing.
Any establishment that is required to register is required to pay the user fee for establishment registration. To pay the fee you must first set up or access your user fee account on the Device Facility User Fee website. Be aware that this is a different account and is separate from your electronic registration and listing FURLS account.
Once you have paid the annual registration user fee, by accessing the payment website, you will be emailed a Payment Identification Number, or PIN. Once the payment has cleared a Payment Confirmation Number, or PCN, will be sent to you. You need both your PIN and PCN to complete the FURLS registration.
You can not register unless you have them as you will not be able to complete the process. Do not attempt to register before receiving both the PIN and the PCN as you will not be able to save any information you enter in FURLS and will have to re-enter everything when you return.
You must pay the fee for each establishment facility that is registered. The fee schedule is defined in the Medical Device Use Fee Amendments 2012 which is part of the Food and Drug Administration Safety and Innovation Act.
FDA allows for several payment methods. Payments can be made on-line electronically using credit cards and automated clearing house electronic checks. Payments can also be made by mailing a paper check. Please make sure the PIN is written on the check, the funds are in U.S. currency, drawn on a U.S. Bank and the check is payable to the Food and Drug Administration. Wire transfers can be used to make the payment as well. Establishments are responsible for paying all wire transfer fees.
For additional information on registration and listing, please visit the resources on this slide.
If you have any questions, please feel free to contact the CDRH Registration and Listing Helpdesk using the email addresses on this slide. One is for assistance on the registration and listing process, and the other is for assistance with registration and listing policy or import detention issues. Thank You.