To obtain FDA certification for a Class I medical device in the United States, the process is relatively straightforward as these devices are subject to general controls rather than extensive premarket approval. Here is a step-by-step guide to help you through the process:

1. Determine if Your Device is Class I

• Confirm that your device qualifies as a Class I medical device. Most Class I devices are subject to general controls, and they usually do not require premarket approval or 510(k) clearance, though there are exceptions for certain devices.

2. Register Your Establishment

• Register your manufacturing facility with the FDA using the FDA Unified Registration and Listing System (FURLS).
• All medical device manufacturers, repackers, and relabelers must register their establishment with the FDA. This is a mandatory step for all medical devices, including Class I.
• Cost: There are no fees for Class I device establishment registration.

3. List Your Device

• After registering your establishment, you need to list the device with the FDA in the FURLS system. This involves providing details about your device, such as its name, intended use, and classification.
• Device listing ensures the FDA is aware of the device being marketed in the U.S.

4. Ensure Compliance with FDA Regulations

• General Controls: Your device must comply with general controls under the FDA’s regulations, including:
  • Good Manufacturing Practices (GMP): You must follow the Quality System Regulations (QSR) as specified in 21 CFR Part 820.
  • Labeling Requirements: Your device must meet the FDA’s labeling requirements outlined in 21 CFR Part 801.
  • Recordkeeping: Maintain appropriate records and implement systems for post-market surveillance to monitor the device's safety and performance.

5. No 510(k) Required (for Most Class I Devices)

• 510(k) Exemption: Many Class I devices are exempt from the 510(k) premarket notification process, meaning you do not need to submit a premarket submission to FDA for review before marketing the device. However, check if your device is exempt, as some Class I devices (especially those with specific regulations like radiation-emitting devices) may require a 510(k).

6. Begin Marketing the Device

• Once your establishment is registered, and your device is listed, you can legally market and sell your device in the United States. Ensure that you comply with all FDA regulations during manufacturing and marketing.

7. Annual Renewal

• Establishment Registration and Device Listing need to be renewed annually. The renewal process is straightforward and is done through the FURLS system.

Summary:

Obtaining FDA certification for a Class I medical device involves the registration of your establishment, the listing of your device, and ensuring compliance with general controls like GMP and labeling requirements. The process is generally quick (a few weeks) and does not require a 510(k) submission unless your device falls under special regulations.

Contact Us：

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