A better process for new medical devices

摘要

The U.S. Food and Drug Administration's (FDA's) public health mission requires a balance between facilitating medical device innovation and ensuring that devices are safe and effective. Contrary to Paul Citron's assertion in "Medical Devices: Lost in Regulation" (Issues, Spring 2011), applications to the FDA for breakthrough technologies increased 56% from 2009 to 2010, and FDA approvals for these devices remained relatively constant.