Has anyone released a nonconforming product under concession? The product in question is a multianalyte control in which one of the analytes failed to meet our acceptance criteria. Since all of the other analytes are in spec we are considering releasing the product with concession (21 CFR 820.90(b)(1). Customers would be notified that the value for the failed analyte would not be available.
Does anyone have any experience with this kind of situation? If so, how did (would) the FDA regard the release?

This is a 510k class II medical device

Thanks

Has anyone released a nonconforming product under concession? The product in question is a multianalyte control in which one of the analytes failed to meet our acceptance criteria. Since all of the other analytes are in spec we are considering releasing the product with concession (21 CFR 820.90(b)(1). Customers would be notified that the value for the failed analyte would not be available.
Does anyone have any experience with this kind of situation? If so, how did (would) the FDA regard the release?

This is a 510k class II medical device

Thanks

Hi and welcome to the Cove

Refer to this informative thread - Concession Procedure FDA Guidelines - medical devices (http://elsmar.com/Forums/showthread.php?t=12560).

Pl note that if the concession resulted in a change of product specifications (form, fit or function), the change should be evaluated for possible 510(k) submission.