Reforms needed for FDA’s regulation of medical devices

Stat News

3 December 2021 - Medical devices are mainstays of modern medicine, from basic products like gloves and bandages to complex technologies like pacemakers and infusion pumps. 

Given the wide range of risks and benefits, Congress tasked the FDA in 1976 with determining whether new medical devices should be authorised for use based on their potential to help or harm patients.

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Michael Wonder

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Michael Wonder

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US , Regulation , Review , Device