The registration process for Class I medical devices in the United States is relatively straightforward compared to higher-risk devices. Here's an overview of the key steps involved:

1. Determine if the Device is Class I

• Class I devices are considered low risk and are subject to the least regulatory control. They include products like bandages, surgical instruments, and tongue depressors.
• Check the FDA's Device Classification Database or consult with the FDA to determine whether your device falls into Class I.

2. Establish FDA Registration

• FDA Registration: Manufacturers and distributors of Class I devices must register with the FDA. This is typically done through the FDA’s Unified Registration and Listing System (FURLS).
• Registration Requirement: You must register your establishment with the FDA before marketing your device in the U.S. This applies to domestic and foreign manufacturers.

3. Device Listing

• After registering your establishment, you must list each medical device you intend to market. This is done in the Device Registration and Listing section of the FURLS.
• No Premarket Approval or 510(k) Submission Required: Most Class I devices are exempt from premarket approval and the 510(k) notification process, which is required for Class II and Class III devices. However, there are some exceptions where a Class I device may still require a 510(k) submission (e.g., if it is a device with a special control or a new product).

4. Comply with FDA General Controls

• While Class I devices are generally exempt from premarket review, they must still comply with FDA's general controls, which include:
  • Quality System Regulations (QSR): The FDA requires that manufacturers follow QSR under 21 CFR Part 820, which outlines the quality management system requirements for medical device manufacturers.
  • Labeling Requirements: Devices must comply with FDA labeling regulations (21 CFR Part 801), ensuring proper instructions and safety information.
  • Establishment Inspection: The FDA may inspect the manufacturing facility to ensure compliance with QSR and other applicable regulations.
  • Adverse Event Reporting: Manufacturers must report any adverse events related to their device as per the Medical Device Reporting (MDR) requirements under 21 CFR Part 803.

5. Post-Market Surveillance

• Although Class I devices do not require premarket approval, manufacturers must still ensure that their products remain safe and effective once on the market. This includes:
  • Monitoring for complaints, malfunctions, and adverse events.
  • Recalls: If necessary, manufacturers must comply with the FDA’s regulations regarding product recalls.

6. Annual Registration Renewal

• Registration must be renewed annually. The FDA requires that manufacturers pay an annual registration fee (unless exempted), and the registration must be updated accordingly.

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