Regulatory Open Forum

Hello! My company wants to submit a 510k for a device (Class II) with the intent to be placed on the market as a sterile kit containing other legally marketed devices. The kit will contain 3 components (eg. A, B, C where A is the subject device for the 510k, B and C are legally marketed devices from other manufacturers). The CMO would manufacture and provide the device A in a non-sterile version to my company, where we will be packaging, labeling and sterilizing the device A  with devices B and C. The intended use of Device A will not be different from the kit. What would be the most reasonable regulatory pathway for device A?  Additionally, what should be the testing strategy (worse case selection) for the performance testing? 

My first preference would be to try and leverage FDA's convenience kit enforcement discretion policy thereby keeping your 510(k) limited in scope and complexity to just Device A.

In a nutshell, the convenience kit policy requires (among other things) that your sterilization (or other additional processing) of legally marketed Devices B and C won't compromise the safety or effectiveness of those Devices.  But if your sterilization (or other additional processing) of those devices could compromise the safety or effectiveness of those Devices, then they will be required to be included in the scope of your 510(k).

To substantiate that your sterilization (or other additional processing) of legally marketed Devices B and C won't compromise their safety or effectiveness, you should be consulting their manufacturer(s).  Repeat sterilization is one of the biggest concerns, if not the biggest concern, that FDA has regarding convenience kits.

The performance testing strategy depends on the particular nature and characteristics of the subject device(s) with respect to FDA's existing classification regulation(s) along with, where applicable, proper application of FDA design controls.  We will need to know the specific device type in order to advise on the performance test strategy.

Hello! My company wants to submit a 510k for a device (Class II) with the intent to be placed on the market as a sterile kit containing other legally marketed devices. The kit will contain 3 components (eg. A, B, C where A is the subject device for the 510k, B and C are legally marketed devices from other manufacturers). The CMO would manufacture and provide the device A in a non-sterile version to my company, where we will be packaging, labeling and sterilizing the device A  with devices B and C. The intended use of Device A will not be different from the kit. What would be the most reasonable regulatory pathway for device A?  Additionally, what should be the testing strategy (worse case selection) for the performance testing?