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What is the process for Class I medical device certification in the United States?
Category：企業(yè)動(dòng)態(tài) Date：2024-12-16 17:22:39 Author: Source:
The process for Class I medical device certification in the United States involves the following key steps:

The process for Class I medical device certification in the United States involves the following key steps:

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  1. Device Classification: Class I devices are typically low-risk and are subject to the least regulatory control. Most Class I devices are exempt from premarket notification (510(k)), meaning they do not require FDA clearance before being marketed.

  2. Establishment Registration: Manufacturers and importers of Class I devices must register their establishment with the FDA. This is done annually through the FDA Establishment Registration system.

  3. Device Listing: After establishment registration, manufacturers must list the devices they are producing or importing with the FDA through the Device Listing process. This helps the FDA track the devices that are being marketed.

  4. Compliance with Quality System Regulations (QSR): Even though Class I devices are low-risk, manufacturers must comply with the FDA’s Quality System Regulations (QSR). These regulations establish requirements for manufacturing processes to ensure product quality and safety.

  5. Labeling Requirements: Class I devices must meet FDA labeling requirements, including clear and accurate product descriptions, intended use, and safety warnings as applicable.

  6. FDA User Fees: While most Class I devices are exempt from 510(k) clearance, manufacturers still need to pay FDA user fees for establishment registration and device listing.

  7. Postmarket Surveillance: Manufacturers are required to monitor their devices after they enter the market. This includes reporting any adverse events, conducting recalls if necessary, and complying with any other postmarket surveillance requirements.

By following these steps, manufacturers can legally market Class I medical devices in the United States.

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