FDA CDRH Washer/Disinfector 510(k) Draft Guidance

FDA CDRH “Guidance On the content and format of Premarket Notification 510(K) Submissions Of Washers and Washer/Disinfectors” draft for comment Issued August 4,1998. Section K addresses software documentation requirements for ventilator submissions by indicating the the general software submission guidance applies and the software should be considered of “Moderate” concern. This is a change from the guidance issued in 1993 which considered it of major concern. Note, however, that this 1998 version is a draft document.

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