CMC File Content and what is common to share with the customer

Marc said:

For those of us who are not Medical Device specialists, what does CMC stand for?

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nadavreu said:

Hi everyone,
We are Company specializing in protein Extraction and purification (we are in process to gain FDA approval ), recently one of our customer requested CMC file as part of his QSR.
Q: Is there any CMC (Chemistry, Manufacturing and Controls) format\templet ? What usually CMC file include and what is common to share with the customer?
Need your HELP
Thanks!
Nadav

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bio_subbu said:

Refer Guidance for Reviewers Instructions and Template for Chemistry, Manufacturing, and Control (CMC) Reviewers of Human Somatic Cell Therapy Investigational New Drug Applications (INDs)

FDA Guidance documents on "Chemistry, Manufacturing, and Controls (CMC)"

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Is there CMC for medical device\ what is applicable to device?