An internal document from the U.S. Food and Drug Administration defends the agency’s rejection of European standards for approving medical devices, according to a report in the Minneapolis-St. Paul Star Tribune.
The FDA document amounts to the agency’s defense of its own practices, and describes 12 classes of allegedly “unsafe and ineffective” high-risk medical devices approved for sale in Europe but not the United States.
According to the Star Tribune, the United ...
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