Urometrics 9-March-99 Penile tumescence monitors

1. Failure to establish and maintain procedures for the identification, documentation, validation, or appropriate verification, review and approval of design changes before their implementation as required by 21 CFR 820.30(i) in that there is no data to show that the NEVA program version 2.2.1 (revised 1/20/99) was validated or verified. The NEVA Program Released Software Description for version 2.2.1 references testing that was performed on earlier versions of the software rather than the final version.