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....Read More

Medical Equipment Designs 9-March-99 Diathermy devices Since 1990, you also modified the design of the Meditherm by introducing software to control the device. Major changes in the intended use of the Meditherm and design changes which could significantly affect safety or effectiveness, such as the introduction of software, require a new premarket notification (510(k)) submission...Read More

In response to your inquiry concerning the need to maintain manual discard records when the same date is computerized, I can assure you that duplicative, manual records are not required, PROVIDED your computer system(s) are validated to ensure that all necessary data is entered, that the stored data is safely backed-up in the event of...Read More