03

Nov

1997

FDA CDRH 510(k) Electrocencephalograph Devices

devicecenter, fda

0

“Electroencephalograph Devices Guidance for 510(k) Content Draft Document Version 1.0”

This document was released for comment on November 3, 1997. It defines on a draft basis a list of hardware and software specifications to be included as part of the 510(k) submission for electroencephalographs.

Section II.B describes that information on the software should identify the various software components of the software, the undesirable events or hazards that may occur, the risk to the patient, corrective actions, and the level of concern of the software. It states that it should also include a discussion of the safety features implemented as a result of the hazard anaylsis, and that these safety measures should address both environmental influences and random software component failures. Finally it states that the information should include a software structure chart depicting the particioning of the system into functional units, the heirarchy and organization of those units, and the communication interfaces.

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