FDA Guidance: Medical Device Data Systems, Image Storage Devices, and Image Communications Devices, 2/15

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In February, 2015, the CDRH and CBER branches of the FDA published Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices: Guidance for Industry and FDA Staff.

The FDA issued this guidance document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to Medical Device Data Systems (MDDS), Medical Image Storage Devices, and Medical Image Communication Devices, due to the low risk they pose to patients and the importance they play in advancing digital health.

A Medical Device Data Systems is defined as hardware or software products that transfer, store, convert formats and display medical device data. A MDDS does not modify the data, and it does not control the functions or parameters of any connected medical device. MDDS are not intended for active patient monitoring.

A Medical Image Storage Device provides electronic storage and retrieval functions for medical images.

A Medical Image Communication Device provides electronic transfer of medical image data between devices.

For devices that meet the definitions above, the FDA does not intend to enforce compliance with the regulatory controls, including registration and listing, pre-market review, post-market reporting, and quality system regulation for manufacturers.