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In the report, CDRH said the agency is looking to use "big data" warehouses to facilitate regulatory decision-making and to promote the safety and quality of medical devices.
Since then, the office was headed up on an acting basis first by former CDRH Associate Director Joanne Less for several months before she was appointed director of FDA's Good Clinical Practice Program, and then by OCP Associate Director Patricia Love.
To read the entire text of this report go to the CDRH homepage at www.
Under federal law, the CDRH determines the safety standards for laser products.
The CDRH Test Stand allowed surveys to be performed with a standard geometry allowing consistent calculations of results.
Helfgott co-developed the Software Education Program for the CDRH Staff College through the Medical Device Fellowship Program.
According to the report, the CDRH wants to develop human factors research tools and apply engineering principles into device design and usability, which are areas associated with many device recalls and adverse events.
associate director for technology and innovation at CDRH.
Food and Drug Administration (FDA) mandates a laser power limit of 5mW for visible hand-held laser pointers (equivalent to CDRH Class IIIa or IEC Class 3R).
CDRH is not equipped to understand the science behind many cutting-edge device technologies, says a Nov.
Daniel Schultz, director of CDRH, said in a briefing with reporters.
Daniel Schultz, director of CDRH, during a briefing with reporters.
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