K
Our company has a Class II device that received a 510(k) SE determination in 1994. The device is now exempt per the Food and Drug Administration Modernization Act of 1997. We now are looking at making changes to that device.
Do we have to update the 510(k) at any point, or do we simply have to document internally as normal for the DHF?
Do we have to update the 510(k) at any point, or do we simply have to document internally as normal for the DHF?