FDA Exempts Medical Device Data System from All Medical Device Regulation


On February 9, the FDA issued a final guidance document essentially deregulating Medical Device Data Systems (and the similar Medical Image Storage Devices and Medical Image Communications Devices). MDDS devices provide electronic transfer, storage, or display of medical device data, or the electronic conversion of medical device data in accordance with a present specification. MDDS devices may not be used for analyzing or manipulating the data, generating signals that control another medical device, or active patient monitoring.

As stated by the FDA, due to the low risk these devices pose to patients and their importance in advancing digital health the agency does not intend to enforce compliance with the regulatory controls that otherwise would apply even to Class I devices that are exempt from premarket notification requirements. This is a rather unusual step, and it essentially exempts MDDS devices from all regulation, even establishment registration, device listing, and post-market reporting of adverse incidents.

The FDA moved quickly on this issue, following up its draft guidance issued only eight months earlier. Draft guidances often take years to become final, and many linger in draft form seemingly forever. Indeed, by taking this action in a guidance document rather than pursuant to a more time-consuming rulemaking proceeding, the FDA was able to streamline the deregulation of such devices. This is an important step that should encourage industry to develop more MDDS devices, which the FDA described as the "foundation" for inter-communication necessary for "better, more efficient patient care and improved health outcomes" offered by digital health technologies.