New technologies for patients with end-stage renal disease: the US regulatory perspective.
Provost
M C
MC
US Food and Drug Administration, Center for Devices and Radiological Health, Office of Device Evaluation, Division of Reproductive, Abdominal, and Radiological Devices, Gastroenterology and Renal Devices Branch, Rockville, Md., USA. mxp@cdrh.fda.gov
Meyers
C M
CM
D018795:Device Approval; D004864:Equipment and Supplies; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D006435:Renal Dialysis / Q000295:instrumentation*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence