06-28-05 06:16 AM - Post#2090 In response to Anonymous
Hopefully this will be more enlightening than the last reply. The best thing to do is to determine who the reviewing division will be and request advice via a pre-IDE. This will open the dialog for your specific application and allow you to ask specific question and FDA to provide specific advice, and point you to pertinant guidances. Depending upon the device, performance using blood samples may be in order, but it may not be called a clinical trial. Prospective collection of samples may be required and also not called a clinical trial. If a sample is taken from a person then permission for it's use must be obtained. This is informed consent. An IRB may determine that a collection can be done with waived consent, but htere won't be much information about the blood donor. The use of unlinked, de-identified samples and informed consent is still debated within FDA.