The costs of FDA certification for medical devices in the United States can vary depending on the device classification, the regulatory pathway, and other factors. Here's a breakdown of potential costs:

1. 510(k) Premarket Notification:

   • Filing Fee: The FDA charges a filing fee for 510(k) submissions. As of fiscal year 2024, the fee is approximately $19,870 for standard submissions. For small businesses, there is a reduced fee of about $4,970.
   • Additional Costs: Additional costs may include testing, clinical trials, regulatory consulting, and preparation of submission documents, which can range from a few thousand to tens of thousands of dollars, depending on the complexity of the device.

2. Premarket Approval (PMA):

   • Filing Fee: The FDA charges a filing fee for PMA applications, which is significantly higher due to the more extensive review process. In fiscal year 2024, the fee is approximately $382,200 for standard submissions. For small businesses, the fee is around $95,550.
   • Additional Costs: PMA submissions typically require more clinical data, extensive testing, and larger-scale studies, leading to higher costs, often in the range of $500,000 to several million dollars depending on the complexity of the device and the clinical trials needed.

3. Other Fees:

   • Establishment Registration and Device Listing Fees: Manufacturers must register their establishments with the FDA and list their devices. The annual registration fee is around $6,000 for large businesses.
   • Quality System Inspection (QSI): If FDA inspections are required, this could add additional costs for preparation and compliance.

4. Consulting and Legal Fees: Many companies hire regulatory consultants, legal experts, or third-party testing labs to help with FDA submissions. These costs can range from $5,000 to $50,000 or more depending on the complexity of the submission and the device.

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