The device, Sedasys, is used to mildly sedate patients in preparation for routine medical tests. The sedative’s label requires that it be administered by an anesthesiologist. Despite endorsement by a panel of advisers, the FDA rejected the device.
Upon its rejection of Sedasys, the FDA asked Johnson & Johnson for more data involving anesthesiologists in the control group. Johnson & Johnson responded that the FDA never brought up the idea of including anesthesiologists in the control group prior to the rejection.
The rejection has only heightened criticism of the FDA’s regulatory and approval process. The process has come under fire in recent months from device makers who say it places unnecessary burdens on manufacturers.
Read the Wall Street Journal report on Johnson & Johnson and the FDA.
Read more on the FDA:
–FDA Releases Final Rule on Software, Hardware Used With Medical Devices
–FDA Draft Guidance: Recommended Warning for Surgeon’s and Patient Examination Gloves That Use Powder
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