The Journal of the American Medical Association
(JAMA) and the American Journal of Therapeutics
(AJT) have both published papers criticizing
the way in which the Food and Drug Administration
(FDA) approves medical devices. Citing a
lack of legitimate safety and effectiveness
studies, the papers allege that the
FDA is approving medical devices without
proper scientific evidence proving that
they work and will not harm patients.
from the University of California, San Francisco,
pored over seven years worth of FDA public
summaries concerning approved medical devices.
Researchers from Beth Israel Deaconess Medical
Center in Boston wrote the AJT piece, concluding
that the FDA's safety and effectiveness
data for medical devices is inconsistent
and unreliable. William Maisel, one of the
researchers, indicated that the
FDA needs to improve its clinical trial
standards for medical devices.