Regulatory Open Forum

Hello

I have several clients who are practicing physicians.  They have novel but mostly class I devices.  Several of them have asked me about allowing hospitals to use devices in non significant risk trials or studies and have the hospital perform the derive packaging and sterilization.  For some reason this seems commonplace in the physician/ hospital community.  As far as I am aware, a device has to either have a completed sterilization validation or be provided with instructions on how to sterilize the devices.  Is anyone else familiar with this practice and how to navigate from the device regulatory perspective?

Thanks 

Michelle

First, I presume you are encouraging them to clearly document that these are NSR studies. As such, the IRB is responsible for oversight. In which case, I'd do a couple of things to cover the regulatory bases in these situations.

- establish in the NSR documentation how it will be cleaned/sterilized and why this does not turn the study into a significant risk study

- additionally, be very clear about how the device will be cleaned/sterilized and what data establishes adequacy in the IRB packet/protocol

At this point, if the IRB agrees, they should have covered all the regulatory bases - because you are not required to fully meet QSR requirements for investigational devices as long as you establish how not doing so does not put patients at risk and have the approval from the correct oversight body (IRB or FDA, depending)

That said, the rationale should be solid. I can see cases where it is a SS instrument using a typical hospital flash cycle with no complex geometry where a paper rationale should be perfectly adequate. I can also see cases where doing some type of validation would seem necessary.

g-

ps - in theory, they should also have such rationales for other parts of the QSR, such as design controls :-)

Hello

I have several clients who are practicing physicians.  They have novel but mostly class I devices.  Several of them have asked me about allowing hospitals to use devices in non significant risk trials or studies and have the hospital perform the derive packaging and sterilization.  For some reason this seems commonplace in the physician/ hospital community.  As far as I am aware, a device has to either have a completed sterilization validation or be provided with instructions on how to sterilize the devices.  Is anyone else familiar with this practice and how to navigate from the device regulatory perspective?

Thanks 

Michelle