Basics and Significance of Product Code

It is 3 letter code found on 510k clearance letters. Public information allows access to decide the type of submission for the device. Appropriate databases are provided by FDA to access product codes.

Product Code:

It is 3 letter code found on 510k clearance letters. Public information allows access to decide the type of submission for the device. Appropriate databases are provided by FDA to access product codes. It has a prominent role in both 510(k) and Premarket Approval (PMA) submissions. FDA reviews the code for accuracy. 

Product codes may be replaced under the following conditions: 

  • As new product codes are generated due to new technology and old ones become outdated, FDA may reassign a device to a new code.
  • If a product code is allocated in an Investigational Device Exemption (IDE), this code may defer from that of the final clearance or approval.
  • New indications for use are established.
  • A device’s technology elevates new questions of safety and effectiveness.

 

Significance of Product Code:

  • To identify and recognize similar medical devices for selection of predicate devices in 510k submission.
  • To provide easy access in the classification of the product.
  • To track the Intention of the Device.
  • To ensure correct device identification to assign responsibility within FDA for classification and oversight of the recall, correction, or removal.

 

Product Code Classification Database

The Product Classification Database includes the names of medical devices and information related to them that was developed through the Center for Devices and Radiological Health (CDRH) to support the fulfilment of their mission. This database has names for devices as well as their product codes. The product code and the name define the general category as defined by FDA. Its Product Code assigned to a device is based on the classification of medical devices defined by the 21 CFR Parts 862-892.

 

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