This is a confusing and unclear topic - there is a narrow and confusing line between PHS Act (21CFR316) and medical device. Autologous tissue that is "minimally processed" for its "usual use" is regulated under 316. But - much depends on how FDA interprets those 2 terms. There really isn't much guidance - in some ways you are better off to read Warning Letters on the topic.
At times FDA has chosen to not regulate the cells, but the equipment used to make the cells (see a variety of stem cell approaches).
I suspect that hospitals etc who do this in their own labs will basically be left alone, but anyone who tries to commercialize equipment or processes to do so will probably have to work through their specific case with FDA.
g-
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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 02-Oct-2019 17:39
From: Anonymous Member
Subject: Bioengineered Organs Future Regulatory Pathway
This message was posted by a user wishing to remain anonymous
Dear Regulatory Experts,
Many academic and commercial groups are working on development of autologous bioengineered organs with various manufacturing approaches including recellularization of cadaver organs and 3d printing. I am wondering how these products will be regulated in the U.S. Is there existing regulation that would cover an autologous bioengineered organ? If you are aware of any resources on the topic please post them. I haven't found anything specific on the FDA OTAT page.
Kind regards,
Sincerely interested