THE FDA’s REGISTRATION PROCESS FOR MEDICAL DEVICES

THE FDA's REGISTRATION PROCESS FOR

MEDICAL DEVICES

The FDA's Registration Process For Medical Devices

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INTRODUCTION

To monitor public health more effectively, the United States government has issued regulations requiring organizations that manufacture and distribute devices to register with the Food and Drug Administration.

Any corporation or individual looking to market a device in the United States should understand the regulations and processes involved in registration.

REQUIREMENTS FOR REGISTRATION

Per the FDA Amendments Act of 2007, Title 21 Code of Federal Regulations Part 807, and authorizations of the United States Congress, domestic owners of corporations that manufacture and distribute devices, people who operate a business that manufactures devices, foreign owners who import devices, and designees are required to register their facility with and pay a fee to the FDA once per year. Small businesses must pay the same fees as larger businesses and foreign manufacturers are required to select a United States Agent to act on their behalf.

Per the amendments to the Medical Device User Fee Modernization Act, manufacturers must submit the annual registration electronically between October 31 and December 31 unless the FDA has granted them a waiver. Organizations performing an initial registration should submit the information within thirty days after they start manufacturing or distributing the device. Importers are also required to register with the FDA. Otherwise, the device will not be allowed into the United States.

Most organizations that register with the Food and Drug Administration must also list the devices that they make and the activities that they conduct at their facilities. If the device requires a premarket approval or a 510(k) Premarket Notification, the organization should also provide the premarket submission number.

THE REGISTRATION PROCESS: GENERAL CONSIDERATIONS

In order to register, the owners of an organization must complete two steps:

1. First, they must pay the annual fee. This annual fee can be paid electronically via the Device Facility User Fee website. After paying this fee, they will receive a payment identification number and information on how to obtain a payment confirmation number via e-m ail once the payment has cleared.

The FDA's Registration Process For Medical Devices

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Owners cannot proceed with registration until they have received this payment confirmation number.

2. After paying the annual fee, they should submit the annual registration and listing information electronically via the FDA's Unified Registration and Listing System/Device Registration and Listing Module. Each owner or operator must have an account identification and password to use the listing system. If the owner or operator has chosen another person to act as an official correspondent, the owner must create a subaccount that includes a separate identification and password for that person.

INITIAL REGISTRATION

To obtain an initial registration, owners should pay the fee and obtain a payment identification number and a payment confirmation number. Then they should go to the FDA's Unified Registration and Listing System/Device Registration and Listing Module website here. Owners or operators who have never registered a device establishment before should create an account. Otherwise, they should use the account that they previously created to log onto the website. Then they must select "Device Registration and Listing Module" and "register a medical device facility" from the options.

Users who do not have any existing registrations should leave the boxes that ask them to identify the owner number, operator number, or registration number blank and select "no existing OO or registration number."

The system will display a list and ask the owners to confirm that they have no previously existing registrations on the list. Owners should not create a duplicate record if the establishment is already registered. However, the owners should select "register a new facility" if the establishment does not appear on the list.

The system will display the owner, operator, or official correspondent information that the company entered when it originally created or revised the account. If the information is accurate, the owner, operator, or importer should select "continue registration." Otherwise, they should exit the system and select "account management."

Owners, operators, and importers should add the appropriate information for the facility and select "continue registration." The system will then prompt the owners or operators to enter information about the devices that they manufacture or distribute. The owners or operators must list all devices that they manufacture.

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If the device is being imported, the initial importers should list the companies involved in manufacturing the device or devices that they import. The information on facilities and devices listed by owners and operators must include devices produced or processed at and whether a premarket approval or notification is required.

For premarket submissions that have been approved, the owners or operators should include the premarket submission number, the proprietary name, and the activities performed on the device. If the device is exempt from premarket approval or notification, owners or operators should enter the product code into the filter box and select "filter." They should then select the button next to the product code and select "continue." They should then identify the activities performed on the device and enter the proprietary names.

Importers are exempt from identifying information on facilities and operators. However, they are required to identify the manufacturers of the device. To do this, they should click on the "search and add products" button and select "identify manufacturers." Then they should identify the manufacturer by the device listing number, the establishment registration number, or the name and address of the establishment.

After owners, operators, or importers have entered all information, they should determine that all the information is accurate and select "submit." The system will then prompt them to enter the payment identification number and the payment confirmation number. After entering this information, they will receive a confirmation that the registration is complete. If they need to make any changes to the registration, they should return to the main menu and select "change, cancel, or reactivate listings."

ANNUAL REGISTRATION

Owners, operators, or importers conducting the annual registration should pay the annual fee and obtain the payment identification number and the payment confirmation number. Then they should use their identification and password to access the Food and Drug Administration's Unified Registration and Listing System website. They should then click on the Device Registration and Listing Module button and select "annual registration" from the main menu. They should review and update the information as appropriate. Once that have determined that all the information is correct, they should click "submit." Afterwards, they should enter the payment identification number and the payment confirmation number previously assigned to them. They will then receive a confirmation that their registration is complete. If they need to make any changes, they should return to the main menu and click on "change, cancel, or reactivate listings."

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CONCLUSION

By registering their devices and the facilities that manufacture them, owners, operators, and importers can provide the government with a better understanding of where devices are developed. As such, they will meet legal requirements and also will enable the government to respond to public health emergencies more effectively.

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