FDA Eases Data Device Rules

The Food and Drug Administration will no longer require premarket approval of electronic devices that record, display, transmit and convert medical data but don't analyze or process the information.

The FDA determined that general controls for Medical Device Data Systems, or MDDSs, "provide a reasonable assurance of safety and effectiveness for this device type. ... [T]he risks associated with MDDSs are generally from inadequate software quality and incorrect functioning of the device itself."

The FDA's move, announced earlier this week in the Federal Register and going into effect in 60 days, is welcome news for device manufacturers. In down-classifying the devices from Class III to Class I, the FDA is lifting cumbersome and potentially expensive premarket notification and approval processes.

Manufacturers of Class 1 devices must still register with the FDA and meet the administration's quality system regulations, but premarket testing is up to the manufacturer. Quality system regulations govern how devices are designed, manufactured, packaged and labeled, as well as the facilities and controls used in those processes. The regulation "significantly reduces the risks of inadequate design and unreliable performance," the FDA says.

The FDA clarified that active patient monitoring devices, such as heart-rate monitors, are not considered MDDSs. It also changed its rules to allow devices used by people other than health-care professionals to still be defined as MDDSs.

The change has been in the works for three years.