Letter to the FDA Regarding Use of Experimental Pulse Oximeter Devices in the SUPPORT Study
August 2, 2013
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Public Citizen previously sent letters to Secretary of Health and Human Services Kathleen Sebelius raising serious concerns about the neonatal SUPPORT study. These letters highlighted important omissions, as well as misleading statements regarding the nature and risks of the research, in the consent forms used in the study. We now pose questions regarding the intentionally miscalibrated pulse oximeter devices used to measure the blood oxygen levels of the premature infants in the SUPPORT Study.
August 20, 2013, Initial response from the FDA