Question

You have modified your 510(k) cleared device with a special 510(k). In which of the following cases would you need to create a new listing for the device?

A. You have added new sizes and shapes in the product portfolio.
B. You have changed the material composition of the device.
C. You have changed the package of the device.
D. None of the above.

Answer 1

You would not necessarily need to create a new listing for adding new sizes, changing material composition, or altering the package of a 510(k) cleared device. The need for a new listing or further regulatory action depends on whether the modification affects the safety or effectiveness of the device.

Step-by-step explanation:

If you have modified your 510(k) cleared device with a special 510(k), the need to create a new listing depends on the nature and extent of the modifications. When it comes to the scenarios provided:

• Adding new sizes and shapes might not require a new listing; however, it does depend on whether the changes affect the safety or effectiveness of the device.
• Changing the material composition of the device could have implications for safety and might require a new 510(k) submission, but not necessarily a new listing unless the material change affects the intended use or alters the regulatory classification of the device.
• Changing the package of the device does not typically require a new listing unless the packaging change could affect the safety or effectiveness of the product, for example, through new sterilization methods or changes in shelf life.

Therefore, the correct answer is D. None of the above.