Under the current leadership of Jeffrey Shuren, M.D., the FDA's Center for Devices and Radiological Health (CDRH) -- the arm of the agency that oversees medical devices -- has become mission-corrupted, placing industry interests over public health.
Failures of the CDRH have harmed countless people and led to many preventable deaths.
CDRH is "captured" by industry. Division managers at the CDRH have close working relationships with representatives of medical device manufacturers.
Fraud and data tampering occurs regularly in FDA clinical trials of medical devices. The CDRH's oversight of device trials is weak and ineffective, leading to approval or clearance of unsafe devices.
Post-market surveillance by CDRH is lax. Problems with medical devices go undetected, which leads to injuries to unsuspecting American citizens.
Patient advocacy groups and whistle-blowers who reach out to the CDRH to raise a red flag about problems with a medical device have been shut out or ignored. MedWatch reports of device-related injuries fall into a black hole at the agency.
We call on the United States Congress to remove CDRH director Jeffrey Shuren from the FDA so that a new leader can take his place. A new CDRH leader must honor the agency's mission to protect and promote the public health.
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