FDA Continuing Work to Improve Sound Development of Medical Products
Regulatory science efforts cited in the report range from providing device designers with computer modeling of cardiovascular devices to developing standard tests for the durability and performance of spinal disc implants. The document is intended to give clinicians, researchers, patient groups and the medical device industry an idea of the scope of the scientific activities at CDRH and how they support device innovation and protect public health.
The FDA report was released nearly two months after the New England Journal of Medicine published an editorial in which it agreed with the Institute of Medicine that the FDA's 510(k) medical device approval program for evaluating safety and effectiveness must be overhauled. The journal also pointed to ongoing lawsuits on metal-on-metal hip implants that could cost Depuy Orthopaedics up to $1 billion.
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