Regulatory considerations for a traumatic brain injury (TBI) indication for hyperbaric oxygen (HBO2).
Hyperbaric Medicine Division, Intermountain LDS Hospital, Salt Lake City, Utah, USA. lindell.weaver@imail.org
Lindell K
LK
Weaver
Cheryl
C
Dicks
Kayla
K
Deru
R Scott
RS
Miller
D001273:Atmosphere Exposure Chambers / Q000592:standards; D001930:Brain Injuries / Q000628:therapy*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D006931:Hyperbaric Oxygenation / Q000295:instrumentation / Q000379:methods / Q000592:standards; D012109:Research Support as Topic; D014481:United States; D014486:United States Food and Drug Administration