PR Notice 94-4 MOU on Regulation of Liquid Chemical Germicides Intended for Use on Medical Devices
This memorandum of understanding with the Food and Drug Administration establishes roles for regulation of liquid chemical germicides intended for use on medical devices. The amendment to the June 4, 1993 Memorandum of Understanding between the Food and Drug Administration and the Environmental Protection Agency revises the disclaimer statement required to appear on the labels of all liquid chemical germicides, other than sterilants that have received FDA premarket clearance or approval.