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How to Apply for Class I Medical Device Certification in the United States?
Category：企業(yè)動(dòng)態(tài) Date：2024-12-10 17:13:38 Author: Source:
To apply for Class I medical device certification in the United States, the following steps generally need to be followed:

To apply for Class I medical device certification in the United States, the following steps generally need to be followed:

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  1. Determine Device Classification: Ensure that the device falls under Class I. Most Class I devices are subject to general controls and do not require premarket approval or premarket notification (510(k)).

  2. Establish Compliance with FDA Regulations: Class I devices must comply with the FDA's general controls, which include:

    • Establishing Good Manufacturing Practices (GMP): This is typically done through the FDA’s Quality System Regulation (QSR).
    • Labeling Requirements: Your device must be labeled in accordance with FDA guidelines.
    • Registration and Listing: The manufacturer must register their establishment with the FDA and list the device in the FDA’s database.

  3. Submit FDA Registration and Listing: Manufacturers must submit a device listing to the FDA via the FDA Unified Registration and Listing System (FURLS). This listing must include the device's intended use and classification.

  4. Compliance with FDA Regulations: Ensure that the device complies with relevant FDA regulations, such as:

    • 21 CFR Part 820 (Quality System Regulations): These guidelines ensure the manufacturing processes are consistent and meet FDA requirements.
    • Labeling (21 CFR Part 801): Ensure your device’s labeling complies with FDA rules.

  5. 510(k) Exemption: Most Class I devices are exempt from the 510(k) premarket notification requirement, but some may still require it depending on the specific device type. Verify if your device is exempt by reviewing FDA’s regulations or consulting an expert.

  6. Keep Records and Monitoring: After approval and marketing, ensure continuous compliance with FDA regulations, including proper record-keeping and post-market surveillance.

If your Class I device is exempt from premarket notification, the process will primarily involve the registration and listing of the device with the FDA.

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