Medical Device Data Systems Guidance

FDA has published a guidance, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, with the agency’s current thinking on the listed devices to provide clarity and predictability for their manufacturers. The document notes that FDA down-classified medical device data systems (MDDS) from Class 3 to Class 1 on 2/15/2011. Since then, it says, the agency’s experience with the devices indicates they pose a low risk to the public.

A 2/9/2015 guidance said FDA did not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to the public and the importance they play in advancing digital health.

This guidance is now being revised, FDA says, to be consistent with a 4/9/2021 final rule on medical device classification that reflects changes made under the 21st Century Cures Act.