Product Registration in the US

Medical Device Product Registration with US FDA

Introduction

Manufacturers who want to sell their medical devices in the United States (U.S.) need to register their products with the U.S. Food and Drug Administration (FDA).

FDA review teams thoroughly examine all of the submitted data related to device and make a decision to approve or not to approve it.

How to Bring a Device to the Market

1. Classify the device and understand applicable regulatory requirements
2. Identify and prepare the correct premarket submission
3. Premarket submission to the FDA and interaction during the review
4. Establishment of registration and device listing

Classification of Medical Device

Parameters for Classification of Devices

Device classification depends on the:

• Predicate Analysis
• Indications for use
• Risk with respect to the device

If your device is classified as Class I or II, and if it is not 510(k) exempt, a 510(k) will be required for marketing.

For Class III devices, a premarket approval application (PMA) will be required.

To find the classification of your device, as well as whether any exemptions may exist, you need to find the regulation number that is the classification regulation for your device directly through the classification database and search for a part of the device name, or the device panel.

Approval Process for Medical Device

For Class I and Class II exempt Devices:

• Determine the classification of the device through the FDA classification database
• In the absence of Local presence in US, appoint an US agent for contact with the FDA
• Pay fee for the Registration
• List the device and register your company using the FDA Unified Registration and Listing system (FURLS) on the FDA website
• Market Approval

For Class II devices requiring 510(k):

• Determine the classification of the device through the FDA classification database
• Establish a Quality Management (QMS) system according to FDA Quality System regulation (QSR)
• Submit the Relevant application Fee as per Medical Device User Fee Amendments (MDUFA)
• Conduct clinical studies, if required
• Prepare and submit a 510(k) pre-market application
• Application Reviewed by the FDA
• If approved, FDA issues 510(k) clearance letter
• In the absence of Local presence in US, appoint an US agent for contact with the FDA
• List the device and register your company using the FDA Unified Registration and Listing system (FURLS) on the FDA website
• Pay fees for Establishment Registration and Listing, which must be renewed each year
• Market Approval

For Class III devices requiring PMA:

• Determine the classification of the device through the FDA classification database
• Establish a Quality Management (QMS) system according to FDA Quality System regulation (QSR)
• Submit the Relevant application Fee as per Medical Device User Fee Amendments (MDUFA)
• Conduct clinical studies if required
• Prepare and submit a Pre Market Approval Application (PMA)
• Facility Inspections involved in design & production of the device by the FDA (for high risk devices)
• Application Reviewed by the FDA
• If approved, FDA issues PMA approval letter
• In the absence of Local presence in US, appoint an US agent for contact with the FDA
• List the device and register your company using the FDA Unified Registration and Listing System (FURLS) on the FDA website
• Market Approval

Process for Applying for Registration of Medical Devices

The registration of a medical device establishment is a two-step process.

• Step 1: Pay the annual registration fee electronically.
• Step 2: Registration of your Facility.

There are mainly two types of Registration:

1. Initial Registration- For new users

   • Make payment and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
   • Go to FURLS and create an account for the owner/operator.
   • Once you have set up your FURLS account ID and password, select the DRLM button (Device Registration and Listing Module).
   • Select the link "Register a Medical Device Facility" from the DRLM main menu.
   • You will see a page that asks you to identify any existing owner operator (OO) number or registration number for your establishment, select "No existing registration or OO number."
   • Select "Register a New Facility."
   • The Owner/Operator and Official Correspondent information that you entered when you created or updated your FURLS account will be displayed. If no changes are required select 'Continue Registration'.
   • Enter the required information for your facility and select 'Continue Registration'.
   • You will be prompted to enter information about the devices that you manufacture, process, distribute, or import. Manufacturers, processors, and distributors must list all the devices produced and processed at each facility.
   • Certify the information and submit.
   • You will receive a confirmation screen after entering both PIN & PCN numbers.

2. Annual Registration- Already have an account

• • Make payment and obtain the Payment Identification Number (PIN) and the Payment Confirmation Number (PCN) at the Device Facility User Fee website.
  • Log on to FURLS (https://www.access.fda.gov/oaa/) using your FURLS account ID and password.
  • Select the DRLM button (Device Registration and Listing Module).
  • Select the "Annual Registration" link from the DRLM main menu. You must select the Annual Registration link and complete this process.
  • Review the registration information for your establishment and make any updates.
  • Review your listing information and make updates, if needed.
  • Certify that all the information is correct and click on the Submit button.
  • You will receive a confirmation screen after entering both PIN & PCN numbers.

Types of Submission

Medical devices that are high or moderate risk are subject to review under one of these regulatory pathways based on the device classification:

• A Premarket Approval (PMA), when the device is high risk (discussed above in Premarket Approval (PMA) for High-Risk Medical Devices)
• A De Novo Classification Request, when the device is low to moderate risk and there is no legally marketed predicate device
• A Premarket Notification [510(k)], when the device is low to moderate risk and there is a legally marketed predicate device