Patrick Giuliano, Abbott Structural Heart Abstract: Acceptance sampling in the medical device industry typically takes it’s direction from ANSI Z1.4 (AQL attribute) and sometimes even ANSI Z1.9 (variable) sampling plan tables, of which, ~ 99% of US medical device companies today who perform IQC inspection employ some version of ANSI Z1.4. ANSI Z1.4 and its associated zero acceptance number (c=0) sampling plan derivative (Squeglia) are widely used because of their explicit endorsement by the FDA, in its Medical Device Quality Systems…