• Medical

FDA Agents Inc.

U.S. Agent and Registration of Food Facilities Worldwide
for the United States Food and Drug Administration

Medical Device Registration and Regulations and
US Agent Requirements

Once a year, FDA sends the registration to all registered firms to be verified, corrected, and returned by the firm as a yearly registration.

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

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

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.

An establishment means any place of business under one management at one physical location at which a device is manufactured, assembled or otherwise processed for commercial distribution. The "owner/operator" of the establishment is responsible for registration. Owner/operator means the corporation, subsidiary, affiliated company, partnership, or proprietor directly responsible for the activities of the registering establishment.

Registration of an establishment is not an approval of the establishment or its devices by FDA. That is, it does not provide FDA clearance to market. Unless exempt, premarketing clearance 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.

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 (21 CFR 807.20). This includes manufacturers, contract manufacturers, contract sterilizers, 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 sold or leased directly to the end user.

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

Wholesale distributors of devices, who do not manufacture, repackage, process, or relabel a device, are not required to register their establishment with the FDA. 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.

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.

In addition, foreign establishments must provide FDA with the name, address, phone and fax numbers, and email address of the qualified United States FDA Agent representing their establishment. The requirement for foreign manufacturers and exporters to register and identify a United States agent became effective February 11, 2002.

Definitions of establishment types are provided below. Please note that most establishments are also required to list their devices.

Effective February 11, 2002, all foreign establishments must notify FDA of the name, address, phone and fax numbers, and email address of their United States FDA Agent. Even if an establishment manufactures various medical devices, drugs, and/or biological products, each establishment can identify only one qualified United States FDA Agent.

The responsibilities of the United States FDA Agent are limited. They 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 FDA Agent, and such an action shall be considered equivalent to providing the same information or documents to the foreign establishment. The United States FDA 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)

An owner/operator of an establishment must register themselves and each establishment they own and operate within 30 days after entering into any activity requiring registration, including processing devices for exportation outside of the U.S.

Foreign establishments must register, name the United States FDA Agent, and list their devices prior to exporting to the U.S. Foreign establishments must also name their United States FDA Agent. If they fail to do so, their documents will not be processed.

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

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.

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.

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

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

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.

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: 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.

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.

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.

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

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.

FDA Agents Inc.

U.S. Agent and Registration of Food Facilities Worldwidefor the United States Food and Drug Administration

Medical Device Registration and Regulations and US Agent Requirements

U.S. Agent and Registration of Food Facilities Worldwide
for the United States Food and Drug Administration

Medical Device Registration and Regulations and
US Agent Requirements