Product: AccuPulse Model 6505 oxygen conserver, Bonsai Velocity oxygen conserver, Evolution oxygen conserver, Evolution with Motion oxygen conserver, SmartDose oxygen conserver, Smart Does Mini oxygen conserver, Oxymizer Disposable oxygen conservers, and oxygen Regulators.
4. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,
a. Your software development /validation:
i. does not include written procedures covering the development/validation of the software used in your devices;
ii. documentation for your Evolution Oxygen Conserver device does not include structural testing at the code level (use of static code checkers, independent code review, etc); and
iii. software product testing procedure, Database/Software Controls IQP 030 Rev A dated 10/20/08, does not require structural testing and does not include provisions for the adequate description of regression testing.
We reviewed your firm?s responses and conclude that they are not fully adequate.
a) The revisions to your software procedures and the initiation of the added testing requirements do not appear to timely relative to the criticality of this deficiency.
FDA District Office: Florida District