FDA to Reduce Consumer Device Testing

FDA to reduce pre-market testing for consumer devices

Food & Drug Administration to reduce pre-market testing for many consumer devices

As the healthcare industry continues to find ways to make operations more efficient, the Food & Drug Administration is now joining in the trend. The FDA has listed a large number of consumer health devices as exempt from pre-market review, noting the “devices identified (…) are sufficiently understood and do not present risks that require pre-market notification”. Device categories include a range from anesthesiology and cardiovascular devices to general hospital and personal use devices. These devices can now go to patients faster, providing quicker resource options, and freeing more resources for the FDA. To read more, click here.

Sources:

http://venturebeat.com/2014/08/01/fda-will-exempt-more-consumer-health-devices-from-pre-market-review/

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM407292.pdf.

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