“Failure to adequately establish procedures for design validation, as required by 21 CFR 820.30(g). Specifically, QS-57532 (Rev. 2.0, “WI-Customer Validation Process”) allows for devices that have not yet fully completed design validation, including software validation, to be shipped to end users for clinical use on patients in a “Limited Availability” basis for the purpose of collecting additional feedback prior to the completion of design validation activities. Further, the Merge HEMO V10.0 was shipped to [redacted] end users for clinical use in cardiac catheterization procedure labs as part of the firm’s design validation plan as a “Limited Availability” release; these devices had not been fully validated. Additionally, document number HEMO-6830 (Rev. 1.0, “Customer Validation Plan Merge Hemo 10.0) describes the customer validation process conducted at the two end user facilities during the “Pre-Release/Limited Availability” release timelines where it is indicated the software will be used in a “production environment,” i.e. for patient use….”
View the original warning letter.