Another problem is the apparent lack of coordination among the agency's three centers that regulate medical products--the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiologic Health
which leads to inconsistency in inspections.
Daniel Schultz, director of the FDA's Center for Devices and Radiologic Health
, decided to approve the device despite objections from other FDA staffers.
The act established the Center for Devices and Radiologic Health
(CDRH), which is responsible for receiving incident reports, conducting thorough investigations and initiating corrective actions.
It never had to be moved for radiation, it only had to be moved for hazardous material,'' said Ed Bailey, DHS's radiologic health
The new regulations will not apply to private physician offices or other health care facilities that are not hospitals, said Barbara Zimmerman, a senior reviewer at the FDA's Office of Compliance at the Center for Devices and Radiologic Health
in Rockville, Md.
The laboratory will work closely with the FDA's five product centers: the Center for Drugs, Center for Biologics, Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine and the Center for Medical Devices and Radiologic Health
Reported by: Center for Devices and Radiologic Health
The new partnership will enable MCRA clients to benefit from an integrated approach to clinical trial design and implementation in response to changes issuing from regulatory bodies such as FDA's Center for Devices and Radiologic Health
State of New Jersey, Department of Environmental Protection, Bureau of Radiologic Health
The FDA plans to issue final guidance documents this summer and will likely call for premarket data submission for high-risk devices as early as January of next year, said Larry Spears of the FDA's Office of Compliance at the Center for Devices and Radiologic Health
, Rockville, Md.
According to Larry Spears of the FDA's Office of Compliance, Center for Devices and Radiologic Health
, the practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s.
Paul Baldenweg of the Radiologic Health
Branch at the California Department of Health Services inspected Ogden's business and found no evidence that radioactive material had leaked.