The time and costs associated with FDA medical device certification can vary depending on several factors, including the device classification and complexity. Here’s a general overview:

Time

1. 510(k) Process:

   • Review Time: Typically, the FDA aims to review 510(k) submissions within 90 days. However, this timeline can be extended if additional information is requested.
   • Preparation Time: Preparing a 510(k) submission can take several months, depending on the complexity of the device and the completeness of the data provided.

2. PMA Process:

   • Review Time: The FDA's review time for a Premarket Approval (PMA) application is generally 180 days. However, this period can be extended based on the complexity of the device and any additional data requested.
   • Preparation Time: Preparing a PMA application is more time-consuming, often taking over a year due to the requirement for extensive clinical data and documentation.

Costs

1. 510(k) Fees:

   • Standard Fee: For fiscal year 2024, the standard fee for a 510(k) submission is approximately $13,606.
   • Small Business Fee: Eligible small businesses may pay a reduced fee, which is about $3,401.

2. PMA Fees:

   • Standard Fee: For fiscal year 2024, the standard fee for a PMA submission is approximately $357,098.
   • Small Business Fee: Eligible small businesses may pay a reduced fee, around $89,275.

Additional Costs

• Testing and Documentation: Costs for laboratory testing, clinical trials, and preparation of the submission can significantly impact the overall cost.
• Consulting Fees: Engaging regulatory consultants or legal experts to assist with the preparation and submission process may incur additional costs.

It's essential to plan and budget accordingly, considering both the direct fees and the associated costs of preparing the necessary documentation and data.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn