FDA: Data gatherers won't need same OK as med devices
Saying that is providing a “less-burdensome path to market” for low-risk products used with medical devices, the U.S. Food and Drug Administration today set new rules for what it calls Medical Device Data Systems (MDDS) or Class I systems that perform tasks such as storing data collected by a glucose meter or transmitting lab results to a nursing station.
The FDA considers MDDS to be hardware or software products that transfer, store or convert medical device data for future use. Under the new rules, such devices are exempt from premarket review by the FDA. However, the agency said those products still have to meet the quality standards set by the FDA, and their manufacturers must register products with the FDA and report adverse events.