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August 2, 2010updated 26 Oct 2017 1:07pm

FDA and FCC Join Forces on Wireless Medical Devices Regulation

The Federal Communications Commission (FCC) and US Food and Drug Administration (FDA) have signed a memorandum of understanding (MOU) to work together to create an efficient regulatory process for wireless-enabled medical devices and services. Under the MOU, the FCC will oversee the effi

By cms admin

The Federal Communications Commission (FCC) and US Food and Drug Administration (FDA) have signed a memorandum of understanding (MOU) to work together to create an efficient regulatory process for wireless-enabled medical devices and services.

Under the MOU, the FCC will oversee the efficient use of airwaves and the FDA will be responsible for the safety and efficacy of medical devices.

Regulatory authorities will work together to help the US realise the promise that broadband and wireless-enabled medical devices hold for healthcare while protecting consumer safety, the National Broadband Plan said.

FDA Commissioner Margaret Hamburg said the benefits that wireless technologies can provide to healthcare are clear, but to harness their full power a balance should be maintained between innovation and safety and effectiveness.

“Working alongside the FCC, we can improve the efficiency of regulatory processes in areas where our jurisdictions overlap,” Hamburg said.

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