Types of 510(k) Submission

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special and Abbreviated.

 

Traditional 510(k):

The Traditional 510(k) is used for any original device that has not been previously cleared and is not required to go through the PMA process. The Traditional 510(k) is also used for a change to a previously cleared device under 510(k). The FDA generally reviews Traditional 510(k) submissions within 90 days of receipt.

 

Special 510(k):

This type of 510(k) is considered when there is modification to a device however modification should have no effect on intended use or alter the fundamental scientific technology. Examples for these modifications can include:

• Change in environmental specifications

• Change in performance specifications

• Change in ergonomics of the patient user interface

• Dimensional specifications

• Software or firmware

 

Abbreviated 510(k):

Device manufacturers may choose to submit an Abbreviated 510(k) when the submission relies on:

• FDA guidance document(s)

• Demonstration of compliance with special control(s) for the device type, or

• Voluntary consensus standard(s).