The rule classifies these products known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, which exempts them from premarket review.

According to FDA, MDDS are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification.

Prior to this rule, FDA classified these devices under Class III (or high-risk) devices requiring premarket approval or as accessories to an existing medical device.

By down-classifying these devices into Class I, FDA is exempting all MDDS manufacturers from premarket notification and applying the level of regulation required for low risk devices.

The MDDS manufacturers, however, should comply with all Class I requirements including registering with the FDA, listing their MDDS products, reporting adverse events, and complying with FDA’s Quality Systems regulation, the FDA noted.