Hello Community,
We currently plan bicomp. testing for an upcoming 510(k) submission.
According to a device specific standard Leachables testing is expected, e.g. according to ISO 10993-18, and full E&L testing is part of our biocomp. strategy anyway.
In a recent 510(k) for a different device type and different review office the FDA requested us to provide:
"For the chemical characterization study a calibration curve containing a minimum of 5 points should be used." , and
"For GC MS, at least three to five references , and for LC MS, at least five references are needed for each ionization polarity."
Does anybody know if this is a standard FDA requirement across all divisions?
If yes: Where does this requirement come from?
Kind regards,
Michael
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Michael Hottner
Köln
Germany
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