She then worked as a scientific reviewer for the FDA in the Department of Chemistry and Toxicology Devices, OIR, CDRH
, before becoming the director of Engineering and Technical Services at Secure Biomed Evaluations.
The FDA's Center for Devices and Radiological Health (CDRH
) promotes and protects public health by ensuring the safety and effectiveness of medical devices(1) and the safety of radiation-emitting electronic products.(2) FDA's authority comes from the Food, Drug, and Cosmetic Act(3) as amended,(4) and the Electronic Product Radiation Control Act.(5) MRI systems are both medical devices and radiation-emitting electronic products.
Brad Thompson, Member, Epstein Becker & Green; General Counsel, mHealth Regulatory Coalition Bakul Patel, Senior Policy Advisor to the Center Director, CDRH
, FDA (invited) Kyle Peterson, Director, Regulatory & Corporate Affairs, Calgary Scientific Marian Lee, Partner, King and Spalding
From this congressional extension of law, the FDA branched out, creating the Center for Devices and Radiological Health (CDRH
Jeffrey Shuren, director of CDRH
, said that 700 deaths had been associated with device failures, but that it's difficult to determine how many of those resulted directly from malfunctions of the devices.
Such information could be particularly important for patients because many use older devices that are no longer supported by manufacturers, said Mary Brady, associate director for home use initiatives at CDRH
GAO reviewed FDA advisory committee policies and analyzed meeting records for FDA's Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH
Nguyen, who has been with the Office of Device Evaluation for more than a decade and headed the PMA policy office since 2000, was promoted outside CDRH
to director of the Office of Combination Products Jan.
The 85 BCD series of blue DPSS lasers are CDRH
and CE compliant versions of the Kyma 488-nm lasers.
(TSX: VHB), Quebec, met recently with the Center for Devices and Radiological Health (CDRH
), United States (US) Food and Drug Administration (FDA) to discuss the clinical development of its Neurostep(TM), a closed-loop peripheral nerve-sensing and nerve-stimulating medical device.
In September 2002, Larry Kessler, ScD, was appointed Director of the Office of Science and Technology at the FDA's Center for Devices and Radiological Health (CDRH
For more information on the logistics, visit: http://www.fda.gov/cdrh/panel/index.html Click on "Upcoming CDRH
Advisory Committee/Panel Meetings" then on "Details" for the March 25, 2004 meeting.