FDA cuts back oversight of medical device data systems | MassDevice.com On Call

FDA medtech regulators take a giant step back from their usual oversight of data systems that collect medical information from other devices.

MASSDEVICE ON CALL — Makers of medical device data systems caught a major break this month as FDA regulators ruled that devices that collect and store information generated by other devices can' skip the 510(k) process for premarket clearance.

The proposed change in regulation affects a wide range of devices, including wireless scales and glucose meters. The FDA defined "medical device data systems" as:

Food & Drug Administration (FDA)

News Well, On Call, Food & Drug Administration (FDA), Regulatory/Compliance

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