Democratic members of the House Energy & Commerce Committee had asked editors of the New England Journal of Medicine, Archives of Internal Medicine and the Journal of the American Medical Association to review two studies cited by Republicans on the committee.
The editors said one of the studies, released earlier this year by Stanford University researchers, was not fit for publication in a medical journal. The other study, prepared by the California Healthcare Institute and the Boston Consulting Group, “reflects little or no understanding of the complexity of medical devices,” the editors stated.
Read the Mass Device report on criticisms of the FDA device approval process.
http://www.massdevice.com/news/house-dems-take-aim-studies-critical-fda-medical-device-regulation
Related Articles on Criticisms of FDA Device Approvals:
House Committee Chair Accuses FDA of Overregulating Devices
Devicemakers Ask Congress to Ease Regulatory Burdens on Industry
Devicemakers Warn FDA Against Becoming Dependent on User Fees
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