CDRH


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CDRH

(Center for Devices and Radiological Health) A branch of the U.S. Food and Drug Administration that governs medical devices as well as non-medical devices that emit radiation, such as cellphones.

Classes 3, 2 and 1
Class 3 devices are the most critical and must go through rigorous testing before approval, similar to pharmaceutical drugs. Class 2 devices are considered low risk, and manufacturers go through a less rigorous "510k" approval process for new models that are similar to existing products. However, a report released in 2011 by the National Research Center for Women and Families and the Cleveland Clinic showed that several 510k-approved devices in the previous five years had caused serious health problems when they failed to operate properly. Class 1 devices are harmless to users if they fail to operate. See healthcare IT.
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Under the banner of regulatory 'precedent,' managers at CDRH have demanded that physicians and scientists review regulatory submissions employing methods, and accepting evidence and conclusions, that are not scientifically proven and clinically validated.
Patel commented, "We are honored that CDRH chose Cytel as their partner for developing validated, documented, and commercially available Bayesian software.
The committees collected and reviewed input from public meetings, open dockets, data analyses, and input from CDRH staff over the course of several months to prepare the complementary evaluations.
Reviewers can take online or live courses in medical devices, food and drug law, regulatory mandates, the CDRH review process, device design and the impact of human factors.
Once the CDRH has assessed public input, it will announce which recommendations it will adopt, along with projected timelines for doing so, according to a news release from the FDA.
Shuren also acknowledged that the turnover at CDRH is a problem and that keeping staff onboard is essential to the predictability that the agency and industry seek.
We believe focusing the amount of time the sponsor may respond to questions to the panel will allow for a more robust discussion among the experts and provide CDRH with information needed to reach a decision regarding the issue before the panel," according to CDRH officials.
His depth of experience at CDRH and in the Field Organization will be a valuable asset to our clients and to the industry as a whole.
It's unbelievable that after more than five years of 510(k) review of this product--and after being told by the ODE (Office of Device Evaluation) director and the CDRH director to file two separate 510(k) submissions for this device as a surgical mesh--[CDRH Director Jeffrey] Shuren now says that they were wrong," Bisbee said.
Ulatowski, director of the Office of Compliance within the CDRH.
We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews," said CDRH director Jeffrey Shuren, M.
The CDRH also plans to develop a network of external experts to help the agency address scientific issues about new medical device technologies.