Noemi,
The FDA does not specify number of lots, lot sizes, number of samples, etc., this is up to the manufacturer to determine based on statistical evaluation including variations in manufacturing (Cpk), specifications of device, expected performance (reproducibility), patient population, etc. The FDA has issued a number of specific guidance documents for certain tests that might be helpful in understanding what would be expected. Also depending on your product, look at potential predicate device 510(k) Summaries to see if there is any indication on the number of samples, type of analytical performance testing done, and maybe determining number of lots used. The normally expected is three (3) lots at normal production lot sizes or pilot lot sizes (with justification) that may give a good variation.
You can also refer to some CLSI guidance documents
https://clsi.org/standards/ that have also guidance documents for analytical performance studies such as EP05 or EP10. The number of lots that are determined should be documented in the validation protocol or analytical performance testing protocol to provide justification why 1 lot or 10 lots are chosen for use in the performance testing and/or clinical testing.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 19-Jun-2018 10:33
From: Noemi Olivo
Subject: FDA lot size for IVD clinical study
We are conducting a 510(k) clinical study for a Class II IVD. Does FDA have a requirement (recommendation) for the number of lots used (minimum?) for the analytical and prospective clinical tests?
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Noemi Olivo
Milford CT
United States
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