Device Center Detractor Speaks Out At FDA Radiation Meeting
This article was originally published in The Gray Sheet
Managers in FDA's device center "ignored and suppressed" significant public health concerns about imaging systems in their past reviews of some such devices, according to a scientist who spoke at a recent FDA meeting
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Two FDA advisory panels will come together Sept. 9 to consider the latest evidence supporting computed tomography colonography as a general screening tool for colorectal cancer. The technique has been touted as a less invasive option to traditional colonoscopy, but its use has been strongly questioned due to risks from radiation exposure and false positives.
Washington Roundup, August 2012
The latest medical device regulatory and reimbursement news from Elsevier Business Intelligence’s “The Gray Sheet.” This month we report on recent FDA proposals to streamline the 510(k) and PMA submission processes and the ongoing investigation into FDA surveillance of CDRH employee whistleblowers.
Judge Orders FDA To Hand Over Whistleblower Surveillance Documents
In the latest turn of events for FDA, a federal judge has ordered the agency to hand over thousands of documents accumulated from monitoring employees’ communications.