2005D-0043 - Blood Pressure Measurement Devices (Sphygmomanometers)--Accuracy; Draft Revised Compliance Policy Guide; Availability
FDA Comment Number : EC1
Submitter : Ms. Theresa Zuraski Date & Time: 03/09/2005 05:03:31
Organization : AAMI
Device Association
Category :
Issue Areas/Comments
GENERAL
GENERAL
Without commenting on the technical content of the draft guidance, we wish to point out that the standards cited in the FR notice (ANSI/AAMI SP9:1994 and ANSI/AAMI SP10:1992) as the basis for the guidance were superseded in 2002 by a combined revision, designation ANSI/AAMI SP10:2002.