Is the FDA getting ready to crack down on medical device clinical trials?

Michael Causey, Editor & Publisher
eDataIntegrityReport.com
Well, we told you 2010 was going to be a big year for the FDA.
While most of us were enjoying holiday treats or making new year’s resolutions, a leading FDA official said the agency was developing new guidelines designed to establish stricter standards for the data received from tests with human subjects used by medical device makers when they seek approval for a new or altered device.
Dr. Jeffrey Shuren, the acting director of the Center for Devices and Radiological Health, told the New York Times recently that the FDA most likely will soon urge device makers to take steps like using more sharply defined targets to measure the success of clinical trials. The agency may also urge producers to more closely follow patients enrolled in such trials to determine whether the targets are met, Shuren told The Times.
That sound you hear is the new drumbeat saying that the FDA hasn’t been tough enough on medical devices in the past, at least according to JAMA and an article published in the American Journal of Therapeutics which suggest the agency has to get stricter to better protect the public.
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