The certification process for Class I medical devices in the United States is relatively simple compared to Class II and Class III devices. Class I devices are considered low-risk and are generally subject to the least regulatory controls. Below are the key steps involved in the process:

1. Determine Device Classification

• First, ensure that your device is classified as Class I by the FDA. You can check the FDA’s Device Classification Database to verify the classification of your device.
• Most Class I devices do not require premarket approval or a 510(k) submission, but some exceptions apply (such as devices that are subject to special controls or have a specific regulation).

2. FDA Establishment Registration

• Registration Requirement: All manufacturers or importers of medical devices in the U.S. must register their establishment with the FDA through the FDA's Unified Registration and Listing System (FURLS). This is a mandatory step before marketing your device in the U.S.
• This registration must be updated annually.

3. Device Listing

• After registering your establishment, you must list your device with the FDA. This involves submitting details about the device, including its name, intended use, and classification.
• Class I devices are typically exempt from premarket notification (510(k)) unless they are subject to specific regulations.

4. Compliance with General Controls

Even though Class I devices do not require 510(k) approval, they must comply with FDA general controls, which include:

• Quality System Regulations (QSR): Manufacturers must comply with 21 CFR Part 820, which outlines quality system requirements for medical device manufacturing.
• Labeling: Devices must comply with FDA labeling requirements under 21 CFR Part 801, ensuring accurate and adequate instructions for use and safety warnings.
• Medical Device Reporting (MDR): Manufacturers must report adverse events or product defects according to 21 CFR Part 803.

5. No Premarket Approval (PMA) or 510(k) Required

• Most Class I devices are exempt from premarket approval (PMA) or 510(k) submission. However, if the device is a combination product or subject to specific FDA regulations, a 510(k) may be required.
• Some Class I devices that are subject to special controls might require additional documentation, such as performance testing or clinical data.

6. Post-Market Surveillance and Compliance

• Once your Class I device is on the market, you must comply with post-market surveillance requirements:
  • Monitoring for adverse events and complaints.
  • Reporting issues to the FDA as necessary.
  • Recalls, if the device is found to be defective or unsafe.

7. Annual Registration and Listing Renewal

• Manufacturers are required to renew their registration annually with the FDA and may be subject to an annual registration fee.

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