Class 1 Diagnostic Kits - PMA (Parts Manufacturing Approval) Required?

[Bill Goss]

My client manufactures diagnostic kits and we believe these are class 1 medical devices. What is required prior to marketing and selling these kits as far as the FDA is concerned? Do we need to do a 510k like class 3 devices? I do not think so. Also, is there any premarket approvals required for class 1 devices?

 

[Michael Malis]

My client manufactures diagnostic kits and we believe these are class 1 medical devices. What is required prior to marketing and selling these kits as far as the FDA is concerned? Do we need to do a 510k like class 3 devices? I do not think so. Also, is there any premarket approvals required for class 1 devices?

Hi Bill,

You need to confirm what is in these kits. They may have Class I and Class II components that may require 510(k) submission. In other words, you may have Class I product (or higher) that is not exempt from premarket notification.

Regards,
Mike