So a doctor that I work with is interested in starting a lab in his office. More specifically, she wants to culture some adipose-derived mesenchymal stem cells and then re-inject them for some kind of cosmetic procedure. What permits are required (if any) to start a lab in her office? I know that FDA regulations on this aren't really set, but do we need approval from some company before we start doing this procedure? Or does the fact that she is a licensed doctor make everything else irrelevant (since it can just be counted under "medical practice"). Thanks for the help anyone. I hope this means I get a bigger paycheck...haha.
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#2
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Posted 14 April 2010 - 09:40 AM
. There might be local ordinances about having a lab, and also check with your landlord to make sure that the facility is set up with proper ventilation and the like.
There are consultants that can be hired to make sure you are compliant with state/fed regulations. It would be best to contact them.
There are consultants that can be hired to make sure you are compliant with state/fed regulations. It would be best to contact them.
#3
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Posted 25 April 2010 - 04:05 PM
labrat612, on Apr 14 2010, 10:40 AM, said:
. There might be local ordinances about having a lab, and also check with your landlord to make sure that the facility is set up with proper ventilation and the like.
There are consultants that can be hired to make sure you are compliant with state/fed regulations. It would be best to contact them.
There are consultants that can be hired to make sure you are compliant with state/fed regulations. It would be best to contact them.
Thanks labrat. Would you happen to know what ordinances apply to laboratories in California? I found this pdf -http://www.cdph.ca.gov/programs/lfs/Documents/Tutorial%20on%20State%20Laboratory%20Law%2020Feb07.pdf , but I'm try to see how it applies to my case.
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Posted 12 May 2010 - 08:47 AM
Stem cell beginner, on Apr 14 2010, 12:39 AM, said:
So a doctor that I work with is interested in starting a lab in his office. More specifically, she wants to culture some adipose-derived mesenchymal stem cells and then re-inject them for some kind of cosmetic procedure. What permits are required (if any) to start a lab in her office? I know that FDA regulations on this aren't really set, but do we need approval from some company before we start doing this procedure? Or does the fact that she is a licensed doctor make everything else irrelevant (since it can just be counted under "medical practice"). Thanks for the help anyone. I hope this means I get a bigger paycheck...haha.
Uh, yeah, the FDA regulations are set. Any cultured cell is regulated as a drug and needs formal approval. If she just wants to process cells, without culture, the applicable regulations are at 21 CFR 1271. It is a long read!
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Posted 19 May 2010 - 07:13 AM
Stem cell beginner, on Apr 14 2010, 12:39 PM, said:
So a doctor that I work with is interested in starting a lab in his office. More specifically, she wants to culture some adipose-derived mesenchymal stem cells and then re-inject them for some kind of cosmetic procedure. What permits are required (if any) to start a lab in her office? I know that FDA regulations on this aren't really set, but do we need approval from some company before we start doing this procedure? Or does the fact that she is a licensed doctor make everything else irrelevant (since it can just be counted under "medical practice"). Thanks for the help anyone. I hope this means I get a bigger paycheck...haha.
Hi, I am also doing the clincial experiment on Adiose-derived MSC, May i have your msn or email? we can discuss the details on the use of ASC.
