For Class I medical devices in the United States, the FDA certification fees are generally lower compared to higher-risk devices. Here is an overview of the potential fees involved:

1. Establishment Registration and Device Listing Fees

• Establishment Registration: Manufacturers of Class I devices are required to register their establishment with the FDA. The FDA charges a fee for the registration of establishments, but small businesses may be eligible for an exemption or reduced fee.
• Device Listing: There is no separate fee for listing individual Class I devices with the FDA once the establishment is registered.

2. Annual Registration Fee

• The FDA requires annual registration for medical device manufacturers, including those producing Class I devices. As of recent years, the registration fee is approximately $5,500 for standard manufacturers.
• Small Business Exemption: Small manufacturers may qualify for a reduced registration fee or an exemption from fees. The criteria for this include having fewer than 50 employees and annual gross sales of medical devices under $100 million.

3. No 510(k) Fees for Class I Devices

• Most Class I devices are exempt from the 510(k) premarket notification process. Therefore, there are no fees associated with 510(k) submissions for these devices.
• However, if a Class I device is not exempt from 510(k) (for instance, if it is subject to special controls or is a new device not substantially equivalent to an existing one), then 510(k) fees would apply. As of recent data, the 510(k) fee for a standard submission is approximately $19,000 (subject to annual updates).

4. Other Potential Costs

• While most Class I devices do not require premarket approval or 510(k) clearance, manufacturers should still budget for potential costs such as:
  • Quality system implementation (e.g., compliance with FDA’s Quality System Regulations (QSR) under 21 CFR Part 820).
  • Labeling requirements, which may require consultation with regulatory experts.
  • Post-market surveillance and reporting, including costs for adverse event reporting and recall management if necessary.

5. Fee Exemptions for Small Businesses

• The FDA provides exemptions or reductions for small businesses (with fewer than 50 employees and less than $100 million in gross annual sales). These businesses may benefit from a lower fee or exemption from registration fees.
• Fee Waivers: In certain situations, the FDA may waive or reduce fees for small businesses, particularly when financial hardship is demonstrated.

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