Willow Glen Proudly Offers:
$279 FDA Medical Device Establishment Registration & US Agent Service
Initial Importer Service for Medical device.
Free FDA Certificate of Registration
† For small businesses with an approved SBD.
‡ Note: all types of 510(k)s (Traditional, Abbreviated, and Special) are subject to the user fee. However, there is no user fee for 510(k)s submitted to the FDA on behalf of an FDA-accredited third-party reviewer.
Small businesses with an approved SBD with gross receipts or sales of $30 million or less are eligible to have the fee waived on their first PMA, PDP, PMR, or BLA.
Annual Establishment Registration Fee: $5,236
There are no waivers or reductions for small establishments, businesses, or groups – all establishments must pay the establishment registration fee.
Medical Device Registration and Listing
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).
US Congress has authorized FDA to collect an annual establishment registration fee for device establishments. The establishment registration fee is not eligible for a reduced small business fee.
Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE).
The amendments to the Medical Device User Fee Modernization Act require that after September 30th, 2007, all registration and listing information be submitted electronically, unless a waiver has been granted.
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
U.S. Agents for Foreign Medical Establishment
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.
The U.S. agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent.
The automated process will forward an email verification request to the U.S. agent. They will be requested to confirm her/his consent to
act as a representative/liaison on behalf of the foreign establishment. If the U.S. agent denies consent (or does not respond within 10
business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new
U.S. agent to satisfy the regulatory obligation.
Responsibilities of a U.S. agent
The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as
an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee
available to answer the phone during normal business hours.
The responsibilities of the U.S. agent are limited and include:
Assisting FDA in communications with the foreign establishment.
Responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States.
Assisting FDA in scheduling inspections of the foreign establishment.
If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).
Submit registration and /or listing information within 30 days of an establishment beginning an activity or putting a device into commercial distribution. Foreign establishments must register before exporting products to the United States and domestic importers must register before importing products. Reminder that if your device requires premarket notification clearance or approval, you will have to wait until your premarket submission [510(k), PMA, etc.] is cleared or approved to register your establishment and list the device.
Registration information must be submitted each year between October 1 and December 31, even if no changes have occurred.
Listing information must be reviewed each year between October 1 and December 31, at the same time you review your
registration information. Submit any updates at that time.
Who Needs Medical Device Registration and Listing
Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States, including those that are imported for export only, are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment (Title 21 CFR Part 807).
The following establishment types are required to list their devices:
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, prepared, propagated, compounded, or processed 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 Importer - Any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. The initial importer must have a physical address in the United States staffed by individuals responsible for ensuring the compliance of imported devices with all applicable FDA laws and regulations.
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.
Remanufacturer - Any person who 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 intended use.
Reprocessor of Single Use Device - 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.
Medical devices are subject to the adulteration provisions of the FD&C Act under Section 501. The first two provisionsof Section 501 define adulteration for most cases. A device is held to be adulterated if it includes any filthy, putrid, or decomposed substance, or if it is prepared, packed, or held under unsanitary conditions.
When the Medical Device Amendments were added to the FD&C Act, certain conforming laws, applying specifically to medical devices, were added to Section 501. These provisions relate directly to other portions of the Amendments, granting the FDA authority to control performance standards; compliance with premarket approval applications and product development protocol requirements; banning; good manufacturing practices; and investigational device exemptions.
FDA Detention of Medical Device
The common reasons FDA detain a medical device:
The manufacturer is not registered with FDA or not appointed a US Agent.
The exporter/importer is not registered with FDA.
The medical device is not listed with FDA or doesn't have 510(K) clearance or PMA.
The medical device labeling is not complying with FDA regulations.
These sections state that a device will also be considered adulterated if:
It is subject to a performance standard and does not comply with all the requirements of the standard.
It is a Class III device and fails to conform to the requirements for an approved premarket approval application or a notice of completion of a product development protocol.
It is a banned device.
It is in violation of good manufacturing practice requirements.
It fails to comply with an Investigational Device Exemption (IDE).
The misbranding provisions of the FD&C Act in Section 502 cover various aspects of drug and device labeling requirements. Many of the provisions apply to drugs and devices both; however, there are also specific misbranding provisions that apply to only drugs or only devices. The misbranding provisions that apply to both drugs and devices are listed in the following:
A drug or device is deemed to be misbranded if:
Its labeling is false and misleading.
Its packaging does not bear a label containing the name of the place of business of the manufacturer, packer, or distributor, and an accurate statement of the quantity of contents in terms of weight, measure, or numerical count.
Reasonable variations and exemptions for small packages may be permitted.
Any word, statement, or other required information is not prominently placed on the labeling or not clearly stated so as to be read and understood by the ordinary individual under customary conditions of purchase and use.
It is for use by man and contains any quantity of a narcotic or habit forming substance, unless its label bears the name and quantity or proportion of the substance or derivative and the statement "Warning - may be habit forming."
Its label does not bear adequate directions for use. The label must include warnings against use in certain pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application. Adequate directions and warnings must be present when it is necessary to protect the health of the user. Exemptions to this provision may be obtained. The phrase "adequate directions for use" pertains to over-the-counter drugs and device.
It is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling.
It does not comply with the color additive provisions listed under Section 706 of the FD&C Act.
False or Misleading Labeling
The FD&C Act states that a drug or device is misbranded "if its labeling is false or misleading in any particular." "Labeling" includes the label and any other written, printed, or graphic material that accompanies a device and any of its wrappers or containers. Operating and servicing instructions are also regarded as part of the labeling. The labeling must bear adequate directions for use and any warnings needed to ensure the safe and effectiveness use of the device.
Premarket Notification Requirements
Section 510(k) of the FD&C Act requires a manufacturer who intends to market a medical device to submit a premarket notification [510(k)] to the Agency at least 90 days before introducing the device onto the market. Premarket approval status is automatic for all devices found to be not substantially equivalent to preamendments devices.
Based on the information provided in the notification,
the Agency must determine whether the new device
is substantially equivalent to a device already marketed
or if it is not an equivalent device. A non equivalent
device must have an approved premarket approval
(PMA) application or be reclassified into Class I or
Class II before being marketed. The final determination
of whether a device is substantially equivalent or non
equivalent resides with the FDA.