Chronimed 3/2/99 Glucose test strips and meters
5. Failure to establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation as required by 21 CFR 820.30(b). For example, there is no plan for the software validation for Version 104.
6. Failure to ensure that the design input requirements are appropriate to assure that the device will perform to meet its intended use and the needs of the user as required by 21 CFR 820.30(c). For example, there is no documentation identifying the final, desired speculations (inputs) required for the Select GT.
7. Failure to establish and maintain procedures defining and documenting design output in terms that allow adequate evaluation of conformance to design input requirements as required by 21 CFR 820.30(d). For example, acceptance criteria was not established for (i) the comparison of the Select GT to the Supreme II; (ii) the software validation of Version 104 used in both the Select GT and Supreme II meters; and (i ______ for Supreme high control Solution.
8. Failure to perform design validation under defined operating conditions on initial production units, lots, and batches, or their equivalents, as required by 21 CFR 820.30(g). For example, the meters used in the software validation of the Version 104 are not defined as production or demonstration units.
9. Failure to the design validation to ensure that devices conform to defined user needs and intended uses as required by 21 CFR 820.30(g). For example, the critical review meeting report dated December 23, 1997, indicates that the Select GT is marketable. That same meeting report includes concerns relating to software validation, the possible cracking of the on/off button and the recommended actions to address those issues.
