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Medical News & Perspectives
April 20, 2011

FDA Ponders Regulation and Innovation

JAMA. 2011;305(15):1523-1524. doi:10.1001/jama.2011.493

Most hip implants, ventilators, nonimplantable infusion pumps—even a radiology app for mobile phones—have traveled the same road from an inventor's mind to a physician's hands. These devices and thousands of other common medical products reach the market through a federal pathway known as the 510(k) clearance process.

Now 35 years old, the 510(k) process was created as a way for low- to moderate-risk medical devices such as tongue depressors or hearing aids to pass muster with the US Food and Drug Administration (FDA), yet bypass the stringent regulatory requirements that apply to devices considered high risk because their failure or misuse can lead to serious injury or death.