5 Takeaways From FDA Medical Device Data System Guidance

On June 20, the U.S. Food and Drug Administration issued a draft guidance titled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.” The draft guidance announces that the FDA does not intend to enforce compliance with the regulatory controls that apply to Medical Device Data Systems (“MDDS”), medical image storage devices or medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.