Anonymous
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Hi there!
I would like to know when a clinical trial has to be performed with a medical device.
For example: if I use a blood sample during a test, is it a clinical trial? I'm suppose to get an informed consent from each "patient"?
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Anonymous
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In response to Anonymous
What do you think?
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Anonymous
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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.
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S. Isbill
Beginner
Posts: 15
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In response to
There is so little information in the initial question that an adequate answer is impossible.
However, re the response: If a sample is taken from a person then permission for it's use must be obtained. This is informed consent.
Maybe not; if your doctor or a clinical testing lab takes a blood sample during a routine visit, no consent is required. Routine medical procedures that do not involve a clinical study do not require consent. If your test is one required by a clinical study protocol, then consent is needed prior to the test. This includes tests that would not be done if there was no clinical study involved.
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mjgregor
Beginner
Posts: 22
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In response to S. Isbill
Hello,
I suggest you visit my site and register to find the applicable regualtion for clinical trials for medical devices. My site is fully indexed with searchable FDA Regualtions and Warning Letters. Feel free to contact me, as I can step you through the process. Please note I have a great amount of clients that have the same challeges as you. My website and phone # is in my signature.
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mjgregor
Beginner
Posts: 22
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In response to S. Isbill
Hello,
I suggest you visit my site and register to find the applicable regualtion for clinical trials for medical devices. My site is fully indexed with searchable FDA Regualtions and Warning Letters. Feel free to contact me, as I can step you through the process. Please note I have a great amount of clients that have the same challeges as you. My website and phone # is in my signature.
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Mark Khayter
Beginner
Posts: 18
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In response to
Anonymous:
The question is whether or not you want to introduce a new drug or device and test that on humans. You can run clinical trials as long as you obtain IRB approvals of your instituation and follow HIPAA rules. But I understand you are interested in the former.
The food, drug and cosmetic act defines exactly what a drug or device is in 21 USC § 321. In § 355, it tells you how you get approval, and the FDA, who handles these approvals, regulate the details in 21 CFR § 312 (investigational new drugs) and 812 (investigational device excemptions).
Hope this helps.
BTW: the site Michael mentions has moved: it is now at http://www.compliancefda.com. You can find all the information there, plus warning letters to companies who did not do it right.
Best regards,
Mark
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anuvatech
Beginner
Posts: 3
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In response to Mark Khayter
u just visit our site,u will get all the detail
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arf2000
Beginner
Posts: 3
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In response to
Your question is pretty layman.
I'll reply in layman terms.
"if I use a blood sample during a test, is it a clinical trial? I'm suppose to get an informed consent from each "patient"? "
If the Blood Sample is already taken from some place and you've purely testing the device in a R&D setting? = No it's not a clinical trial.
But u'll have to follow certain clinical lab test rules layed out by FDA and EU bloodborne disease management SOP.
If you need blood samples during test from live patient? Forget it!!, too much paper work. If i were you, i'll do it from the R&D setting. during verification and validation testing phase. During the validation test phase in R&D setting, you can mention that the blood samples taken from XYZ would be considered to be relevant to taking it from a live patient....
I'd need more details about your device to say more.
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05-11-05 12:57 AM -