Regulatory Open Forum

Hello,

I am researching the regulatory requirements in the US for a class II IVD device that will be measured using an instrument that will be sold by us.  However, the instrument is developed and manufactured by another company.  The instrument company will provide us software that will allow us to configure the instrument to read our IVD.  The final, configured instrument will provide results to the end-user in the form of both numbers and positive/negative - displayed on the screen of the instrument.  The instrument will be a standalone instrument that does not interface with the end-user's computer. 

My question is what information will the FDA require in our 510k submission in relation to the instrument?  I have read the "Off-the shelf Software Use in Medical Devices" guidance document as well as "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" guidance document.  I'm not sure these apply to our situation.  Are there other guidance documents that are more appropriate or other sources of information available? 

Thank you in advance!

Joy

Hi,

Both of those guidance documents give you the software information you need if the equipment is not yet cleared with another test.  In the event the manufacturer has a clearance, reference that 510k. If there is specific software that is needed to run your test you will need to provide the reports to support that software.  If the equipment is not yet cleared, you will need to work with them to get the information necessary or have them file the information at the same time as your 510k.  A presubmission would be helpful to present this strategy to FDA.

Sarah,

Thank you!  The instrument is not cleared, so would we submit our IVD with the Instrument as a single 510k?  After clearance, if we bring develop new IVDs that use the same instrument, can we reference our original 510k for the instrument portion of the submission?

Joy

The intended use and indication for use would be something like:

"The IVD is an assay intended for the quantitative detection of __________ in serum specimens.  This test is intended for the use as an aid in the diagnosis of __________. 

Special Instrument requirements:  For use with ______ instrument only"

Hello,

I am researching the regulatory requirements in the US for a class II IVD device that will be measured using an instrument that will be sold by us.  However, the instrument is developed and manufactured by another company.  The instrument company will provide us software that will allow us to configure the instrument to read our IVD.  The final, configured instrument will provide results to the end-user in the form of both numbers and positive/negative - displayed on the screen of the instrument.  The instrument will be a standalone instrument that does not interface with the end-user's computer. 

My question is what information will the FDA require in our 510k submission in relation to the instrument?  I have read the "Off-the shelf Software Use in Medical Devices" guidance document as well as "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" guidance document.  I'm not sure these apply to our situation.  Are there other guidance documents that are more appropriate or other sources of information available? 

Thank you in advance!

Joy

Hello,

I am researching the regulatory requirements in the US for a class II IVD device that will be measured using an instrument that will be sold by us.  However, the instrument is developed and manufactured by another company.  The instrument company will provide us software that will allow us to configure the instrument to read our IVD.  The final, configured instrument will provide results to the end-user in the form of both numbers and positive/negative - displayed on the screen of the instrument.  The instrument will be a standalone instrument that does not interface with the end-user's computer. 

My question is what information will the FDA require in our 510k submission in relation to the instrument?  I have read the "Off-the shelf Software Use in Medical Devices" guidance document as well as "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" guidance document.  I'm not sure these apply to our situation.  Are there other guidance documents that are more appropriate or other sources of information available? 

Thank you in advance!

Joy