Company: GE Medical Systems Inc. SA
Date: 4/10/01
Product: Full Field Digital Mammography Device
Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented as required by 21 CFR 820.30(c). For example, design control input failed to assure 2 spot compression paddles (round and square) met the 1 percent of Source-image receptor distance (SID) MQSA/FDA requirement. An USA complaint dated July 2000 documented failure during installation. Field upgrade FMI was implemented to update all units in the field.
Your response is not adequate. Please provide a copy of the completed FMI _____. Provide evidence of implementation of the _____ (_____ System) software tool. Provide documentation of the completion of employee training for the _____ software tool and design controls promised by February 2001. This information is necessary so that a final determination of your corrections can be assessed.
Provide training documentation of supplier auditors trained under the new system _____ Audit tracking software. Also, provide a copy of the new procedure for the audit management software.
FDA District: Rockville, Maryland
