A new $1.3 million report by the Institute of Medicine calls for a complete overhaul of the FDA's 150(k) approval process for medical devices.
"The 510(k) process cannot achieve its stated goals –– to promote innovation and make safe, effective devices available to patients in a timely manner –– because they are fundamentally at odds with the statutes that govern how FDA must implement the process," the report stated.
The Medical Device Manufacturers Association issued a statement rejecting the report's conclusion. "MDMA will continue to closely examine this report, though we completely disagree that the 510(k) pathway is 'flawed' and that the FDA needs to eliminate it," the statement read. The MDMA said a complete overhaul would "create additional uncertainties and slow patient access to medical therapies."
Although the FDA commissioned the report, which took nearly two years to complete, FDA officials distanced themselves from it just before it was released.
Read the IOM report on the FDA device approval process.
Read the MDMA statement on the IOM report.
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