This requires persuading the Food and Drug Administration s Center for Devices and Radiological Health ( CDRH; www . FDA . gov / cdrh ) to update the administrative process and ensure laser light shows and displays are safer for the public.
42.
The risk that patients were exposed to others'blood and thus to blood-borne diseases such as hepatitis or HIV, the virus that causes AIDS, is " extremely remote, " said Steven Niedelman, an enforcement director for the FDA's Center for Medical Devices and Radiological Health.
43.
Dr . Bruce Burlington, head of the FDA's Center for Devices and Radiological Health, said in an interview that the agency was particularly concerned about the pacemaker problem because it appeared to involve a relatively large proportion of patients and the cause was still unknown.
44.
"So far, the results we have seen look reasonably positive, given the fact that this is a very sick patient population and a revolutionary type of device, " said Dr . Daniel Schultz, deputy director of clinical and review policy for the FDA's Center for Devices and Radiological Health.
45.
"I am confident enough in the progress made in assuring the performance of U . S . mammography centers that I would have no reservation whatsoever having my family use any certified facility, " said Dr . David W . Feigal Jr ., the agency's director for devices and radiological health.
46.
While most of the research showed cell phone use had no effect on the human body, Dr . Russell Owen, chief of the radiation-biology branch of the FDA's Center for Devices and Radiological Health, said the two studies " raise some interesting scientific questions but are no cause for alarm ."
47.
The President is . John R . Frazier, who has over 32 years of experience workinking as a health physicist for the U . S . FDA Bureau of Radiological Health ( 1977-1980 ), Oak Ridge Associated Universities ( 1980-1986 ), IT Corporation ( 1986-1993 ), and Auxier & Associates ( 1993-2004)
48.
"It would stifle innovation, " said Dr . Daniel Schultz, director of the FDA's Center for Devices and Radiological Health . " It would force us to authorize marketing of an older technology that we knew was inferior simply because we would not have the time to do another clinical trial ."
49.
"One of the things people fail to recognize is that these crucial devices are never certified as quote ` safe .'It's a risk-benefit balance that they are safe and effective, " said David Feigal, who heads the FDA's Center for Devices and Radiological Health, which oversees the nation's medical device regulatory scheme.
50.
But Dr . Daniel G . Schultz, director of the agency's Center for Devices and Radiological Health, said the agency was advising states about the potential health risks of elective ultrasounds and ensuring that machines were labeled for specific medical functions . " In the end it's up to the states, " he said.
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