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A Step-by-Step Guide to Using the FDA's Product Classification Database

April 3, 2024

When developing a medical device, one of the first steps is to determine its classification according to the FDA's regulations. The FDA's product classification database is a valuable tool that can help you identify the classification of your device and the applicable regulatory requirements. In this blog post, we'll guide you through the process of using this database.


Step 1: Access the Database

To access the FDA's product classification database, go to the following URL:


Step 2: Enter Search Terms

On the search page, you can enter various search terms to find your device. The most common search term is the "Device Name." If you know the specific name of your device, enter it in the "Device Name" field.


If you're unsure about the exact name, you can use more general search terms related to your device's function, such as "catheter" or "imaging." You can also search by "Product Code" if you know the three-letter code associated with your device.


Step 3: Review Search Results

After entering your search term and clicking the "Search" button, the database will display a list of results that match your query. Each result will show the following information:


·      Classification Name: The official name of the device classification.

·      Product Code: The three-letter code assigned by the FDA to categorize the device.

·      Device Class: The risk-based classification (Class I, II, or III) assigned to the device.

·      Regulation Number: The CFR (Code of Federal Regulations) number that applies to the device.


Step 4: Identify the Most Relevant Classification

Review the search results to find the classification that most closely matches your device. Pay attention to the "Classification Name" and "Device Class" to ensure that your device falls under the appropriate category.


If you're unsure which classification applies to your device, you may need to review multiple results or consult with a regulatory expert.


Step 5: Click on the Product Code for More Information

Once you've identified the most relevant classification, click on the "Product Code" link to access more detailed information about the device classification. This will take you to a new page with additional details, including:


·      Regulation Medical Specialty: The medical specialty associated with the device.

·      Review Panel: The FDA panel responsible for reviewing devices in this classification.

·      Submission Type: The type of premarket submission required for the device (e.g., 510(k), PMA, or exempt).

·      GMP Exempt: Indicates whether the device is exempt from certain Good Manufacturing Practice (GMP) requirements.


Step 6: Use the Information to Guide Your Regulatory Strategy

With the information obtained from the FDA's product classification database, you can begin to develop your regulatory strategy. The classification, submission type, and applicable regulations will help you determine the necessary steps for bringing your device to market, such as preparing a premarket submission or complying with GMP requirements.


Remember that while the product classification database is a helpful tool, it's just one part of the regulatory process. You may need to consult additional resources, such as FDA guidance documents or industry experts, to fully understand the requirements for your specific device.


By following these steps and using the FDA's product classification database, you'll be well on your way to determining the appropriate classification for your medical device and developing a sound regulatory strategy.



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