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What are the fees for Class I medical device certification in the United States?
Category：企业动态 Date：2024-12-16 17:24:17 Author: Source:
For Class I medical devices in the United States, the following fees apply:

For Class I medical devices in the United States, the following fees apply:

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  1. Establishment Registration Fee: Manufacturers and importers must pay an annual establishment registration fee to the FDA. This fee is applicable to all medical device establishments, including those involved with Class I devices.

  2. Device Listing Fee: In addition to establishment registration, manufacturers must also list their devices with the FDA. There is no specific fee for listing Class I devices, but it is required as part of the registration process.

  3. FDA User Fees: Although Class I devices are generally exempt from premarket notification (510(k)) and premarket approval (PMA), manufacturers still need to pay user fees associated with establishment registration and device listing.

The exact fees can vary each year, and manufacturers should check the FDA’s official website for the most up-to-date information on the registration fees. For Class I devices, these fees are typically lower than those for higher-risk devices (Class II and Class III).

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