image: Jason Reed / REUTERS

FDA takes cautious approach to new regulations for OEM and third-party device servicers

The US Food and Drug Administration has cited insufficient evidence regarding public health concerns to warrant new regulatory requirements for original equipment manufacturers (OEM) and third-party servicers of medical devices, but will take less formal steps to ensure safety and effectiveness of these entities’ products and services.

In a recent report, FDA addresses the quality, safety, and effectiveness of servicing medical devices.

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