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23 Jun 2010, 8:11 am by Leonard
Children and young women, who are most vulnerable for radiation harm, sometimes get too much at busy imaging centers that don't adjust doses for each patient's size. [read post]
23 Jun 2010, 8:11 am by Leonard
Children and young women, who are most vulnerable for radiation harm, sometimes get too much at busy imaging centers that don't adjust doses for each patient's size. [read post]
18 Feb 2018, 4:22 am by Jon Gelman
“A blood test to aid in concussion evaluation is an important tool for the American public and for our Service Members abroad who need access to quick and accurate tests,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. [read post]
5 Jul 2009, 1:59 am
The new Outpatient Medical Fee Schedule sets forth the maximum limits for payment for of 1) ambulatory surgical centers 2) hospital outpatient surgery, radiology, pathology, laboratory, physical medicine and rehabilitation services and 3) new rates for free standing specialized rehabilitation hospitals.Workers' compensation payment rates are based on the medical procedure code, the date of service and the location (or zip code) where the medical care is rendered. … [read post]
16 Nov 2011, 4:39 pm by FDABlog HPM
  A new SOP issued by FDA’s Center for Devices and Radiological Health (“CDRH”) tries to define the responsibilities of management when CDRH review staff has identified the need to make changes in data requirements from what was requested in other premarket submissions or previous communications with a manufacturer. [read post]
26 Jun 2019, 9:02 am by Tinker Ready
Radiology technician Jeff Dettbarn reported that patients were showing up at the Iowa City VA for CT scans appointments, but they found the sessions had been cancelled. [read post]
29 Oct 2009, 6:36 am
Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says the study likely will identify which patients are at higher risk of poor outcomes and "could lead to a reduction" in those whose eye problems are made worse by the procedure. [read post]
14 Feb 2011, 10:39 pm by FDABlog HPM
Shapiro – FDA’s Center for Devices and Radiological Health (“CDRH”) has proposed the “Innovation Pathway Program” for breakthrough medical devices. [read post]
26 Jun 2019, 9:02 am by Tinker Ready
Radiology technician Jeff Dettbarn reported that patients were showing up at the Iowa City VA for CT scans appointments, but they found the sessions had been cancelled. [read post]
30 Jun 2011, 1:45 pm by FDABlog HPM
  Under the FDC Act and FDA’s implementing regulations, a product that is a “device” is generally subject to the regulatory authority of FDA’s Center for Devices and Radiological Health (“CDRH”), while a product that is a “drug” is generally subject to the regulatory authority of FDA’s Center for Drug Evaluation and Research (“CDER”). [read post]
21 Mar 2012, 11:54 am
At that time, most employees of the FDA’s Center for Devices and Radiological Health trusted agency leadership and felt it was headed in the right direction. [read post]
24 Feb 2011, 1:59 am
 Next month, the Centers for Disease Control and Prevention will be updating its management and disease prevention guidelines for norovirus outbreaks. [read post]
18 Jul 2011, 1:20 pm
., deputy director of FDA's center for devices and radiological health, said in a statement. [read post]
19 Mar 2010, 9:21 am by Richard J. Webb
., radiology, anethesiology, pathology) as required by all hospital patients. [read post]
10 Aug 2012, 9:30 am by Ritika Singh
And all of the most frightening cases—involving chemical, biological, and radiological materials—arose from right-wing extremists or anarchists. [read post]
16 Oct 2023, 2:33 am by Kurt R. Karst
Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year. [read post]
20 Mar 2011, 10:10 pm by FDABlog HPM
The Center for Devices and Radiological Health (CDRH) requires manufacturers and user facilities to submit reports of adverse events within certain time frames. [read post]
18 Jan 2012, 1:59 am
Centers for Disease Control and Prevention (CDC) to mount a comprehensive response to nuclear detonation, radiological attacks, chemical attacks and natural disasters is at risk.Food Industry Relevance: NCEH also plays an important role in retail food safety work. [read post]
Notably, there was a marked decreased in the warning letters issued by FDA’s Center for Devices and Radiological Health (“CDRH”), which sent 42 warnings in 2017 and that was close to half of the 85 warning letters that CDRH sent in 2016. [read post]