Re: How to get a FDA approval before May 2010 / “Quick and dirty” FDA approval
Hi Leifi,
You still missing a few points.
Is it a RUO device or something else? Do you have Software validation?
And, you do need to apply for 510(k) clearance...
What does this mean "inst. + software can help in the study of diseases"? What diseases? What type of help? (Find cure for any type of cancer, can see something better, may or may not to do what? Specifically, what the instrument with new software does better/similar to the existing device?
You also mention, "results from the instrument"... What results? For what reason and by doing what we getting those results? Is it a true RUO? Or you what to do something with those results?
You "would like more involved in Clinical testing? What for? What and Whom do you plan to test and why?
You really need to clarify the above, before you will be able to move forward with the submission or "clinicals"
Regards,
Mike
Hi all and thanks for the replies!
Ok for the conference: It seems that we don’t need any clearance to exhibit there.We mark the instrument and all our literature as “pending 510(k) clearance”.
Combined with the main medical device (which is a FDA class II device), our equipment (hardware+software) captures, stores and displays images, and calculates physiological parameters from those images. So far we have been acquiring data from patients (in Europe) to establish that the instrument and software are actually doing what they are intended to do. The results are promising and show that the instrument+software can help in the study of diseases.
At the conference we will have a lecture and posters with the results from our instrument. We will also have the instrument+software on display (again, marked as “pending 510(k) clearance”).
For further development we would like to get more involved in clinical testing and have been looking for institutes which are willing to gather further data from patients in the US and Europe.
We would like to send/sell the instrument to research institutions (hospitals) in the US and Europe for more research/investigations. In order to do that, will the US institutions in question have to apply for some research/investigational exception from the FDA?
According to: Displaying Investigational and Unapproved Medical Devices According to FDA Policy
Thanks,
Leifi
Ok for the conference: It seems that we don’t need any clearance to exhibit there.We mark the instrument and all our literature as “pending 510(k) clearance”.
Combined with the main medical device (which is a FDA class II device), our equipment (hardware+software) captures, stores and displays images, and calculates physiological parameters from those images. So far we have been acquiring data from patients (in Europe) to establish that the instrument and software are actually doing what they are intended to do. The results are promising and show that the instrument+software can help in the study of diseases.
At the conference we will have a lecture and posters with the results from our instrument. We will also have the instrument+software on display (again, marked as “pending 510(k) clearance”).
For further development we would like to get more involved in clinical testing and have been looking for institutes which are willing to gather further data from patients in the US and Europe.
We would like to send/sell the instrument to research institutions (hospitals) in the US and Europe for more research/investigations. In order to do that, will the US institutions in question have to apply for some research/investigational exception from the FDA?
According to: Displaying Investigational and Unapproved Medical Devices According to FDA Policy
Thanks,
Leifi
Hi Leifi,
You still missing a few points.
Is it a RUO device or something else? Do you have Software validation?
And, you do need to apply for 510(k) clearance...
What does this mean "inst. + software can help in the study of diseases"? What diseases? What type of help? (Find cure for any type of cancer, can see something better, may or may not to do what? Specifically, what the instrument with new software does better/similar to the existing device?
You also mention, "results from the instrument"... What results? For what reason and by doing what we getting those results? Is it a true RUO? Or you what to do something with those results?
You "would like more involved in Clinical testing? What for? What and Whom do you plan to test and why?
You really need to clarify the above, before you will be able to move forward with the submission or "clinicals"
Regards,
Mike