curious
newbie
Posts: 1
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Dear All,
Please, I need your help.
Could you please tell me what kind of clinical & pre-clinical trials are necessary to have in medical devices? Is it possible to perform a phase IV trial (vertebral device) without having previous phases? In my country we only have the legislation for medication and not for devices (devices are not so clear)
Thank you!
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mjgregor
Beginner
Posts: 22
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In response to curious
Hello Curious,
Depending on the type of device will dictate what type of trails are necessary. Perhaps my site may be of help to you. I have many clients in countries other than the US that use my site to ascertain the FDA's Code of Federal Regulations and Warning Letters. May I ask what country you are in?
My site allows you to perform effective key word searches for all 240 regulations and all warning letters issued by the FDA. For example, it would be helpful if you knew what class your medical device is. You can find this out by performing a key word search in the regualtions on my site.
Please feel free to contact me with any questions, as I am happy to help. My contact information is below:
Best regards,
--
Michael J. Gregor
Partner, ComplianceDoc Inc.
978.473.9265 Phone
978.921.2941 Fax
mgregor@ComplianceDoc.com
http://www.compliancedoc.com
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Mark Khayter
Beginner
Posts: 18
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In response to curious
Curious:
The regulations don't stipulate the trials phases. But usually, you have phase I-III trials prior to approval of the drug or device, and phase IV for post-marketing. If you have no approval for your device, you cannot run a phase IV trial. You have to get the approval first. How to do that is regulated in 21 CFR 814.
The website Michael mentioned is very good for researching these kinds of questions, because you have the regulations and the law for full-text search. You also have the warning letters, which tell you how not to do that. If you search there for "adulterated" and "device" you find interesting material.
The name has changed btw: It is now http://www.compliancefda.com.
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mobalityaids
Beginner
Posts: 2
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In response to curious
[image]http://www.marketstrat.com/reports/reports-category/mobility-aids--accessories-worldwide.html[/image]
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05-11-06 01:49 AM -