WASHINGTON – The U.S. Food and Drug Administration has set up a new webpage where the public can report allegations of regulatory misconduct against medical device makers and marketers.
Among the examples of things that might be reported through the webpage are charges that manufacturers or marketers improperly promoted non-FDA-approved uses of products or that companies failed to tell the FDA about “device-related safety concerns” as federal regulations require. […]
Besides prohibited off-label promotion and failure to report potential product-related problems, the FDA said the webpage will be a place to expose devices or manufacturing processes that do not meet government standards, to reveal efforts to hide information from the FDA, or to point out regulatory issues with imported medical devices.
Charges will be assigned tracking numbers, assessed by FDA’s Center for Devices and Radiological Health, and given priority based on the potential risk to patients, the FDA spokeswoman told the Star Tribune. Penalties could include inspections of device facilities, warning letters or recalls.
Sen. Amy Klobuchar of Minnesota applauded the new webpage’s “potential to strengthen oversight and safety of medical devices.”
“All patients deserve to know the risks and side effects of a medical procedure and a medical device in order to make informed decisions about their care,” she said. […]
“This is a good idea, but the question is: what resources will the Center [for Devices and Radiological Health] devote to this to ensure that the allegations of misconduct are followed up and dealt with accordingly?” asked Diana Zuckerman, president of the National Center for Health Research. […]
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