To apply for FDA registration in the United States, you must meet specific requirements depending on the type of medical device you are registering. Below are the general requirements:

1. Determine Device Classification:

   • Your device must be classified according to its risk level. The FDA classifies medical devices into three categories:
     • Class I (low risk): These devices are subject to the least regulatory control. Many Class I devices only require establishment registration and device listing.
     • Class II (moderate risk): Devices in this category usually require a 510(k) premarket notification, which demonstrates substantial equivalence to an existing FDA-approved device.
     • Class III (high risk): Devices in this category require premarket approval (PMA), which is a more detailed and lengthy process, often involving clinical studies and extensive safety data.

2. Establishment Registration:

   • Manufacturers (and initial distributors) of medical devices must register their establishment with the FDA. This includes providing details about the business, its manufacturing facilities, and the devices being produced.
   • Registration is done through the FDA’s Electronic Registration and Listing System (FURLS).

3. Device Listing:

   • Each device you intend to distribute in the U.S. must be listed with the FDA. You will need to provide information about the device, including its intended use, classification, and compliance with relevant standards.
   • This is part of the establishment registration process but is a separate requirement.

4. Appoint a U.S. Agent (for foreign manufacturers):

   • If you are a non-U.S. manufacturer, you must designate a U.S. agent. This is a representative located in the U.S. who will act as a liaison between your company and the FDA. The U.S. agent is responsible for assisting with regulatory communications and inspections.

5. Compliance with FDA’s Quality System Regulations (QSR):

   • Manufacturers must adhere to the Quality System Regulations (QSR), which govern how devices are designed, manufactured, and tested. These are based on Good Manufacturing Practices (GMP) and include requirements for risk management, production controls, documentation, and record-keeping.

6. Premarket Notification (510(k)) or Premarket Approval (PMA):

   • 510(k): If your device is classified as Class II, you must submit a 510(k) notification to demonstrate that your device is substantially equivalent to a legally marketed device. You will need to provide information such as product testing, labeling, and performance data.
   • PMA: If your device is Class III, you will need to submit a PMA application, which requires more extensive clinical data and safety evidence. The approval process can take significantly longer and involves in-depth evaluation by the FDA.

7. Labeling Requirements:

   • The FDA requires that all medical devices have proper labeling, which must include information on the device's intended use, safety, and instructions for use. Labels must comply with the FDA’s labeling guidelines, which include language and format requirements.

8. Payment of Fees:

   • There are fees associated with FDA registration and submissions, including establishment registration fees and premarket submission fees. The fees vary depending on the type of device and submission process (e.g., 510(k), PMA).
   • Payment is typically made via the FDA’s FDA Industry Systems (FIS).

9. Postmarket Surveillance:

   • After FDA registration, you must comply with ongoing postmarket requirements, including:
     • Reporting adverse events (Medical Device Reporting, MDR).
     • Conducting recalls if necessary.
     • Submitting annual registration updates or changes to the device listing.

10. Good Manufacturing Practices (GMP):

    • Ensure compliance with GMP for device manufacturing, which may be subject to FDA inspections. This includes having a documented quality management system in place to ensure that products meet regulatory standards for safety and effectiveness.

These requirements will vary depending on the specific type of device you are registering, and you may need to submit additional information or documentation for certain categories of devices. For Class II and III devices, it is advisable to work with regulatory experts or consultants who can guide you through the submission process and ensure compliance with FDA regulations.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn