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What Are the Costs of Medical Device Certification in the United States?
Category：企业动态 Date：2024-12-12 17:18:09 Author: Source:
The costs of medical device certification in the United States can vary widely depending on the type of device, its classification, and the regulatory pathway required. Here’s a general breakdown of the costs involved:

The costs of medical device certification in the United States can vary widely depending on the type of device, its classification, and the regulatory pathway required. Here’s a general breakdown of the costs involved:

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1. Establishment Registration and Device Listing Fees

  • Establishment Registration: Required for manufacturers and certain other entities (e.g., importers). The annual fee is typically around $5,500 (for 2024).
  • Device Listing: No additional cost, but each device must be listed with the FDA.

2. 510(k) Premarket Notification Fees (for Class II Devices)

  • The 510(k) submission fee for most devices is around $20,000 (for fiscal year 2024).
  • Small businesses (with gross annual sales under $100 million) may qualify for a reduced fee, approximately $5,000.
  • Additional costs may arise from testing, clinical trials, and consulting fees.

3. Premarket Approval (PMA) Fees (for Class III Devices)

  • The PMA application fee for Class III devices is significantly higher, typically around $380,000 (for 2024).
  • Small businesses may qualify for a reduced fee, usually about $95,000.
  • Clinical trial costs, testing, and other expenses will add to the total cost.

4. Other Costs

  • Quality System Regulations (QSR) Compliance: There may be costs associated with implementing and maintaining compliance with the FDA's 21 CFR Part 820 (Quality System Regulations), including inspections, documentation, and record-keeping.
  • Clinical Trials and Testing: Depending on the device, clinical trials, testing, and data analysis can be costly, potentially ranging from tens of thousands to millions of dollars.
  • Consulting Fees: Many companies hire regulatory consultants to assist with the submission process. These fees can range from $5,000 to $50,000 or more, depending on the complexity of the device and submission.

5. Annual Fees

  • In addition to the initial submission fees, some devices may require annual fees for maintenance of registration or other post-market requirements.

Summary of Typical Fees:

  • 510(k) Submission: $5,000 – $20,000 (depending on business size)
  • PMA Submission: $95,000 – $380,000 (depending on business size)
  • Annual Fees: Around $5,500 (for establishment registration)

Costs can vary depending on the specific device, submission requirements, and any additional regulatory or consulting services you need. It’s recommended to consult with a regulatory affairs expert or the FDA for a more precise estimate based on your specific product.

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