To obtain FDA registration for a Class I medical device in the United States, follow these steps:

1. Determine Device Classification

• First, confirm that your device qualifies as a Class I medical device. Most Class I devices are subject to general controls and typically do not require premarket approval or a 510(k) submission. However, some may still require specific testing or additional documentation.

2. Establishment Registration

• Register your establishment with the FDA. This includes registering the manufacturing facility where the device is made or processed.
• Use the FDA Unified Registration and Listing System (FURLS) to submit your registration. All medical device manufacturers, repackers, and relabelers must register their establishment with the FDA.
• Registration is done annually and must be renewed each year. The registration is free for Class I devices.

3. Device Listing

• You need to list the device with the FDA once the establishment registration is complete. The device listing provides details about the device, including its classification, intended use, and labeling.
• Listing is also done through the FDA’s FURLS system. Ensure that your device is listed as a Class I device.

4. Compliance with FDA Regulations

• Even though Class I devices typically do not need premarket approval or a 510(k), they must comply with FDA regulations for general controls, including:
  • Good Manufacturing Practices (GMP): Compliance with Quality System Regulations (QSR) under 21 CFR Part 820.
  • Labeling Requirements: The device must be properly labeled in accordance with FDA guidelines, including clear and accurate labeling per 21 CFR Part 801.

5. Ensure Compliance with Other Applicable FDA Rules

• Recordkeeping and Post-market Surveillance: Manufacturers must maintain appropriate records and have systems in place for post-market surveillance to monitor the safety and performance of the device after it is on the market.

6. Exemption from 510(k) Notification

• Most Class I devices are exempt from the 510(k) premarket notification process, meaning they do not require submission of clinical or performance data to FDA before marketing. However, certain Class I devices may still require it, so always verify the device type against FDA guidelines.

7. Obtain FDA Registration Confirmation

• Once your establishment is registered and your device is listed, you will receive confirmation from the FDA. Your device is now legally marketed and sold in the U.S.

Key Considerations:

• No Test Report Required: For most Class I devices, test reports are not required unless the device is subject to specific regulations (e.g., radiation-emitting devices).
• Annual Renewal: Both establishment registration and device listing must be renewed annually.

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