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U.S. Agent and Registration of Facilities Worldwide
for the United States Food and Drug Administration
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Medical Device and Establishment Registration and 
US Agent Requirements

 

Every company that is involved with production or distribution of medical devices intended for the USA (manufacturer, packager, exporter, importer, specification developer, etc) must: register with US FDA, list the devices by category, and if foreign, must have a US Agent [FDA Agents].

*** Each year by December 31st, each registered company must renew its registration.

**** The new registration or the renewal will be valid now until December 31, 2018

***** US FDA charges each company an annual fee to register or renew, called the US FDA User Fee. For Year 2018 -which starts October 01, 2017 - the US FDA User Fee is 4624 usd.



FDA Agents completes these requirements for you. All you need to do is click the link below. If the link does not connect you, simply email us at support@fdaagents.com and we will complete it in one or two emails. Depending on how many devices you have, it might take only fifteen minutes for you to complete.

We can typically complete new registrations and renewals within three business days.

Start MEDICAL DEVICE LISTING and ESTABLISHMENT REGISTRATION -Click Here Now!

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NOTE: We are pleased to have just one low price that includes:

* registering your company

* listing all your exempt and 510k-cleared medical devices, at no charge for your first five different devices

* serving as your US Agent

* only 65/usd for any added devices throughout the year or in excess of five device listings

* making all changes whenever you need, and

* communicating between the US FDA and you, as required by law.

There are NO extra fees or charges from FDA Agents, and our services are quite cost-effective. Please compare our "fees and services", and if you have questions, simply email us at info@fdaagents.com.

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FDA Agents completes all these requirements for you, and your part of the procedure can be completed by you in fifteen minutes.

Definitions of Establishment Activities

Contract Manufacturer - Manufactures a finished device to another establishment's specifications.

Contract Sterilizer - Provides a sterilization service for another establishment's devices.

Foreign Exporter - Exports or offers for export to the United States (U.S.), a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the United States. A foreign exporter must have an establishment address outside the U.S.

Initial Distributor - Takes first title to devices imported into the U.S. An Initial Distributor must have a U.S. address.

Manufacturer - Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in Section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

Repackager - Packages finished devices from bulk or repackages devices made by a manufacturer into different containers (excluding shipping containers).

Relabeler - Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

Reprocessor of Single Use Devices – Performs remanufacturing operations on a single use device.

Specification Developer - Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment’s name by a contract manufacturer.

U. S. manufacturer of export only devices – Manufactures medical devices that are not sold in the U.S. and are manufactured solely for export to foreign countries.

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What is Establishment Registration

Establishments involved in the production and distribution of medical devices intended for marketing or leasing (commercial distribution) in the United States (U.S.) are required to register with the FDA. This process is known as establishment registration. Registration provides FDA with the location of medical device manufacturing facilities and importers. The regulations for establishment registration are provided in 21 CFR 807. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. Congress has also authorized FDA to implement a user fee for certain types of establishment registrations processed after September 30, 2007. Your registration is not considered complete until FDA has been notified that all requirements have been met.

ESTABLISHMENT Any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution.

OWNER/OPERATOR The corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment. The owner/operator is responsible for registering the establishment.

Registration of an establishment is not an approval of the establishment or its products by FDA. That is, it does not provide FDA clearance to market. Unless exempt, premarketing clearance or approval is required before a device can be placed into commercial distribution in the U.S.

Misbranding by Reference to Establishment Registration Number: Title 21 of the Code of Federal Regulations, Section 807.39, states, "Registration of a device establishment or assignment of a registration number does not in any way denote approval of the establishment or its products. Any representation that creates an impression of official approval because of registration or possession of a registration number is misleading and constitutes misbranding." Product labeling and Internet sites cannot reference your establishment registration number or make reference to your establishment being registered or approved by FDA. If your product labeling or Internet sites list your establishment registration number or makes reference to your establishment being registered and approved by the FDA, then these references must be removed.

Who Must Register

Manufacturers An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a medical device intended for commercial distribution (marketing) is required to register. This includes manufacturers, contract manufacturers and contract sterilizers that place the device into commercial distribution, specification developers, repackagers or relabelers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of components or accessories that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (that is, manufacturers of components or accessories that are intended to be sold or leased directly to the end user.)

Initial Distributor An initial distributor (or importer) takes first title to the devices imported into the U.S. and further distributes the devices. Initial distributors/importers are required to register. However, they are NOT required to list the devices that they import.

Foreign establishments (manufacturers and exporters) Foreign establishments that manufacture, prepare, propagate, compound, or process a device that is imported, or offered for import, into the U.S. are required to register their establishments. This includes contract manufacturers and contract sterilizers. Foreign establishments must also list the devices that they export to the U.S.

Definitions of establishment activities are provided below. Prior to registering your establishment, please review the definitions and determine what type of activities your establishment is performing. Please note that most establishments are also required to list their devices.

Please note that the following groups are not required to register: Wholesale distributors of devices who do not manufacturer, repackage, process or relabel a device. A "wholesale distributor" is defined as any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.

Refurbishers and domestic distributors

Establishment Registration Fee

The following types of establishments are required to pay the establishment registration fee to the US FDA:

Device manufacturers Contract sterilizers Contract manufacturers Single-use device reprocessors Specification developers Initial distributors are not required to pay the fee. The establishment registration fee for some types of activities for year-2010 is 2008 usd.

United States Agent for Foreign Establishments

All foreign establishments must advise and notify FDA of the name, business name, address, phone number, and email address of their designated United States agent. Responsibilities of United States Agent.

The responsibilities of the United States Agent include:

assisting FDA in communications with the foreign establishment, responding to questions concerning the foreign establishment's products that are imported or offered for import into the United States, and assisting FDA in scheduling inspections of the foreign establishment. In addition, if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the United States agent, and such an action shall be considered equivalent to providing the same information or documents to the foreign establishment. The United States agent has no responsibility to report adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or to submit Premarket Notifications [510(k)] (21 CFR Part 807, Subpart E)

The United States Agent must be designated at the time of electronic submission of establishment registration information.

When to Register Domestic establishments must register within 30 days of the establishment entering into any activity requiring registration, including processing devices for exportation outside of the U.S. If you are required to list your devices, you must submit device listing information at the time of initial registration.

Foreign establishments must register, notify us of their United States agent, as well as list their devices prior to exporting to the U.S.

Your registration must be renewd annually each year. The registration period extends from October 1st through September 30th.

How to Register In September, 2007, Section 207 of the Medical Device User Fee Modernization Act of 2002 (MDUFMA) amended section 510 of the Federal Food, Drug and Cosmetic Act (the Act) to require electronic submission of device registration and listing information unless FDA grants a waiver request. MDUFMA also authorizes FDA to collect a user fee for annual registration of certain types of establishments. Effective October 1, 2007, all establishment registrations are to be submitted electronically using FDA’s Unified Registration and Listing System (FURLS), unless a waiver has been granted by FDA.

Please note:

If you are required to list your devices, you must submit that information at the same time as you submit establishment registration information. Establishments must register within 30 days after entering into any activity requiring registration or prior to importing or exporting a device.

Establishments must pay their establishment registration fee and receive notification from FDA that their payment has been received by December 31 of each year for their registration to be considered active and current for the fiscal year (October 1st through September 30th). It can take up to two weeks for your payment to be processed. You are not considered registered for the new fiscal year until FDA has notified you that your payment has been received.

Updating Registration Data All registration information must be verified annually between October 1st and December 31st of each year Establishments must pay their establishment registration fee by December 31 of each year for their registration to be considered active and current for the fiscal year (October 1st through September 30th).

Definitions The establishment activities are defined as follows.

CONTRACT MANUFACTURER Manufactures a finished device to another establishment's specifications and places the device into commercial distribution. (Please note that contract manufacturers are also required to list their devices).

CONTRACT STERILIZER Provides a sterilization service for another establishment's devices and places the device into commercial distribution. (Please note that contract sterilizers are also required to list the devices sterilized at their establishment).

FOREIGN EXPORTER Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the U.S. A foreign exporter must have an establishment address outside the U.S.

MANUFACTURER Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

REMANUFACTURER Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance, safety, specifications, or in any way changes the intended use.

REPACKAGER AND/OR RELABELER Repackager: Packages finished devices from bulk or repackages devices made for the establishment by a manufacturer into different containers (excluding shipping containers). Relabeler: Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

INITIAL DISTRIBUTOR/ IMPORTER Takes first title to devices imported into the United States. An initial distributor must have a U.S. address.

SPECIFICATION DEVELOPER Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.

REPROCESSOR OF SINGLE-USE DEVICES Performs remanufacturing operations on a single-use device.

U.S. MANUFACTURER OF EXPORT ONLY DEVICES Manufactures medical devices that are not sold in the U.S. and are offered solely for export to foreign countries.

Frequently Asked Questions

How much does registration cost? The registration fee for fiscal year 2008 is $1,706. In addition, your US Agent can assist you in rgeistering and listing your medical devices, and appropriate fees are charged annually.

How long is my registration valid? Each establishment registration is valid for one fiscal year (October 1st through September 30th). Firms must complete their annual registration establishment requirement each year for the registration to be valid.

Does registration or device listing fulfill my Premarket Notification 510(k) requirements? No. The establishment registration and device listing requirement is a separate requirement from the Premarket Notification 510(k) submission process. See Device Advice for information on how FDA regulates devices including how to submit a 510(k).

I am a distributor located outside the U.S. Do I have to register?

Yes, foreign exporters must register their establishment, list the devices exported to the U.S., and identify the designated United States Agent.

Are foreign dental and optical laboratories required to register and list? Yes, foreign dental and optical laboratories are required to register and list. They are not exempt from registration and listing. The exemption in 21 CFR 807.65(i) only applies to domestic establishments.

My establishment only does design work. Am I required to register the establishment? Company owned design facilities must register. That is, if a manufacturer owns a manufacturing facility and a separate facility for design work, both must register. Third party design facilities (design contractors) are not required to register. The manufacturer that contracts out the design work is responsible for maintaining the design control documentation in accordance with 21 CFR 820.30.

In addition to registration, foreign companies must also designate a qualified U.S. Agent.

MEDICAL DEVICE LISTING

All medical devices that are manufactured and imported into the U.S. are required to be listed with the FDA. Firms that are required to list their devices are those that:

manufacture,

repackage and relabel,

develop specifications,

reprocess single-use devices,

remanufacture

manufacture accessories and components sold directly to the end user

A separate device listing form must be submitted for each type of device.

MEDICAL DEVICE LISTING as required by the US FDA to export your product to the USA

What Is Medical Device Listing

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. The regulations for medical device listing are provided in 21 CFR 807.

Each generic category is represented by a separate classification regulation found in Title 21 Code of Federal Regulations Parts 862-892 or FDA assigned device name. Each regulation number or device name is associated with one or more product codes. Regulation numbers with more than one product code identifies the product in further detail.

Listing of a medical device is not approval of the establishment or a device by FDA. Unless exempt, premarketing clearance is required before a device can be marketed (placed into commercial distribution) in the U.S.

All device types classified as exempt from the Premarket Notification 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx is replaced with Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware that it is your responsibility to ensure that you meet the exemption criteria and that your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.

Who Must List

An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly or processing of a medical device intended for commercial distribution (marketing) is required to list its device within 30 days of entering the device into commercial distribution in the U.S. This includes manufacturers, repackagers and relabelers, specification developers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of accessories and components sold directly to the end user (21 CFR 807.20). Foreign manufacturers must list their devices prior to importing into the U.S.

Domestic contract manufacturers and contract sterilizers are required to register their establishment and list their devices if they commercially distribute the devices. Initial importers located in the U.S. are required to register their establishment; they are not, at this time, required to list their devices.

The following establishment types are required to list their devices:

CONTRACT MANUFACTURER

Manufactures a finished device to another establishment's specifications and places the device into commercial distribution.

CONTRACT STERILIZER

Provides a sterilization service for another establishment's devices and places the device into commercial distribution.

MANUFACTURER

Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

REMANUFACTURER

Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or in any way changes the intended use.

REPACKAGER AND/OR RELABELER

Repackager: Packages finished devices from bulk or repackages devices made for the establishment by a manufacturer into different containers (excluding shipping containers). Relabeler: Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

SPECIFICATION DEVELOPER

Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.

FOREIGN EXPORTER

Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the U.S. A foreign exporter must have an establishment address outside the U.S.

REPROCESSOR OF SINGLE-USE DEVICES

Performs remanufacturing operations on a single-use device.

U.S. MANUFACTURER OF EXPORT ONLY DEVICES

Manufactures medical devices that are not sold in the U.S. and are offered solely for export to foreign countries.

When to List

An owner/operator of an establishment located in the U.S. that is required to list should do so within 30 days of entering into any activity requiring registration as discussed above under "Who Must List." An establishment located outside of the U.S. must list the device prior to exporting to the U.S.

Foreign establishments must also complete and notify FDA of their qualified United States FDA Agent.

Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles

Sunglasses, spectacle frames, spectacle lens, and magnifying spectacles are medical devices exempt from the Premarket Notification 510(k) submission to the Food and Drug Administration (FDA). Although these devices are 510(k) exempt, several other FDA regulations apply:

* U.S. manufacturers and initial U.S. distributors (importer) must register their establishment with FDA;

** foreign manufacturers must register their establishment with FDA and name a United States Agent;

*** manufacturers must list their device with FDA.

**** manufacturers must meet Quality System (QS) requirements,

***** the lens for spectacles and/or sunglasses must be certified as impact resistant.

Content copyright US FDA and obtained from the US FDA website at www.fda.gov./p>

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We provide here some information for you about Medical Device Listing. This requirement is in addition to the "Establishment Registration" for medical-device companies.

FDA Agents, can take care of all these requirements for you, register your company, obtain listing numbers for your exempt medical devices, obtain your US FDA Registration Number, and serve as your US Agent, for one low, cost-effective fee. Remember also that there is NO fee for "listing" your exempt medical devices, no matter how many medical devices you list.


To begin the online registration for US FDA, simply click REGISTERMEDICAL" here or in the Menu above, and then click the highlighted link you will see.

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What Is Medical Device Listing

Most medical device establishments required to register with FDA must also identify to FDA the devices they have in commercial distribution including devices produced exclusively for export. This process is known as medical device listing and is a means of keeping FDA advised of the generic category(s) of devices an establishment is manufacturing or marketing. The regulations for medical device listing are provided in 21 CFR 807.

Each generic category is represented by a separate classification regulation found in Title 21 Code of Federal Regulations Parts 862-892 or FDA assigned device name. Each regulation number or device name is associated with one or more product codes. Regulation numbers with more than one product code identifies the product in further detail. For example, "Manual Surgical Instruments for General Use," 21 CFR 878.4800, contains several product codes including GAB (disposable suturing needle), GDX (scalpel), HTD (forceps) and HRQ (hemostat).

Listing of a medical device is not approval of the establishment or a device by FDA. Unless exempt, premarketing clearance is required before a device can be marketed (placed into commercial distribution) in the U.S.

All device types classified as exempt from the Premarket Notification 510(k) requirements are subject to the limitations of exemptions. Limitations of device exemptions are found in the device classification chapters in 21 CFR xxx.9, where xxx is replaced with Parts 862-892 (e.g., 862.9, 864.9, etc.). Please be aware that it is your responsibility to ensure that you meet the exemption criteria and that your device does not exceed the limitations of exemption. If your device exceeds the limitations of exemption, you must submit a 510(k) and receive a letter from FDA stating that your device may be commercially distributed in the U.S. prior to marketing your device.

While there is no separate fee for listing your device, device listing is completed as part of the annual registration process. Many device establishment types are subject to an annual registration fee.

Who Must List An owner/operator of an establishment not exempt under 21 CFR 807.65 who is engaged in the manufacture, preparation, propagation, compounding, assembly or processing of a medical device intended for commercial distribution (marketing) is required to list its device with FDA within 30 days of entering the device into commercial distribution in the U.S. This includes manufacturers, repackagers and relabelers, specification developers, reprocessors of single-use devices, remanufacturers, U.S. manufacturers of export only devices, and manufacturers of accessories and components that are ready to be used for any intended health-related purpose and are packaged or labeled for commercial distribution for such health-related purpose (that is, manufacturers of components or accessories that are intended to be sold or leased directly to the end user.) (21 CFR 807.20). Foreign manufacturers and foreign exporters must list their devices prior to importing into the U.S.

Contract manufacturers and contract sterilizers are required to register their establishment and list their devices if they commercially distribute the device. Initial importers located in the U.S. are required to register their establishment; they are not, at this time, required to list their devices.

An establishment is required to list their device(s) if they are performing one or more of the following activities:

CONTRACT MANUFACTURER Manufactures a finished device to another establishment's specifications and places the device into commercial distribution.

CONTRACT STERILIZER Provides a sterilization service for another establishment's devices and places the device into commercial distribution.

FOREIGN EXPORTER Exports or offers for export to the United States, a device manufactured or processed by another individual, partnership, corporation or association in a foreign country, including devices originally manufactured in the U.S. A foreign exporter must have an establishment address outside the U.S.

MANUFACTURER Makes by chemical, physical, biological, or other procedures, any article that meets the definition of "device" in section 201(h) of the Federal Food, Drug, and Cosmetic (FD&C) Act.

REMANUFACTURER Processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or in any way changes the intended use.

REPACKAGER AND/OR RELABELER Repackager: Packages finished devices from bulk or repackages devices made for the establishment by a manufacturer into different containers (excluding shipping containers).

Relabeler: Changes the content of the labeling from that supplied from the original manufacturer for distribution under the establishment's own name. A relabeler does not include establishments that do not change the original labeling but merely add their own name.

SPECIFICATION DEVELOPER Develops specifications for a device that is distributed under the establishment's own name but performs no manufacturing. This includes establishments that, in addition to developing specifications, also arrange for the manufacturing of devices labeled with another establishment's name by a contract manufacturer.

REPROCESSOR OF SINGLE-USE DEVICES Performs remanufacturing operations on a single-use device.

U.S. MANUFACTURER OF EXPORT ONLY DEVICES Manufactures medical devices that are not sold in the U.S. and are offered solely for export to foreign countries.

Please note: Initial distributors ( importers) located in the U.S. are not required to list their devices. However, they are required to register their establishment. Refurbishers and domestic distributors are not required to list their devices or register their establishment.

When to List When an owner/operator of a domestic establishment enters into an activity that requires registration, device listing much be completed at the time of registration for the establishments that are required to list as discussed above under "Who Must List." The owner/operator must also submit a device listing when it introduces a device into commercial distribution that has a classification name or product code that is not currently listed. Foreign establishments must to submit device listings prior to exporting their devices to the United States. Registered establishments are also required to review and update their listing information once per year, during the registration period of October 1st to December 31st of each year. You can update your device listing(s) at any time. We encourage you to update your device listings at time the change occurs.

How to List All listing information (new, updates or annual review) must be submitted electronically unless FDA grants you a waiver. Electronic registration and listing is completed through FDA’s United Registration and Listing System (FURLS).

Updating Listing Data The official correspondent of each establishment is responsible for keeping their listing records current. You can update your device listing(s) at any time through FURLS.

The owner/operator must submit a device listing when it introduces a device into commercial distribution that has a classification name or product code that is not currently listed. We encourage you to update your device listings at time the change occurs. Updating is required when one of the following occurs: All models or variations of a listed device is removed from commercial distribution. That is, the product is discontinued. The commercial distribution of a previously-discontinued device is resumed. There is a change in the type of activity performed on a device, such as where it is being manufactured. You are encouraged to identify proprietary names or trade names to distinguish various models of the same device.

Frequently Asked Questions

How much does device listing cost? There is no fee for device listing. However, many estabishments are subject to a registration fee. You must submit device listing information at the same time as the annual establishment registration requirement each year.

Does the initial distributor/importer have to list the devices that they are importing into the United States? No, initial distributors/importers do not list the devices that they import into the United States. The foreign manufacturer is responsible for listing the devices.

Content copyright US FDA and obtained from the US FDA website at www.fda.gov


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FDA Agents, is not a part of, nor affiliated with, the US Food and Drug Administration or the US Government.