FDA Approval Debate
The cluster focuses on discussions about whether a product or medical device requires FDA approval, its regulatory status, and implications for marketing and use as a treatment.
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Comments
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5
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#8581
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Keywords
FD e.g II US default.htm SmallBusinessRepresentatives SmallBusinessAssistance III ForIndustry FDAI fda approval approved medical product org devices device process regulated
Sample Comments
This looks like it might need FDA approval.
Are these things regulated by the FDA? And if not, why not?
Why would their be FDA trials for this?
Try getting FDA approval for this and see what happens.
Without FDA approval, they are not allowed to market it as treating almost anything medical.
They have FDA approval. It’s stated in the first paragraph of the article.
Sounds like FDA approval process.
Is this something that is in scope for FDA?
They can't. Not FDA approved.
Surely this is a claim that warrants FDA approval.