Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Guidance for Industry and Food and Drug Administration Staff September 2022

GUIDANCE DOCUMENT

• Docket Number: FDA-2014-D-0798
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

FDA is issuing this guidance to communicate how the Agency intends to apply its regulatory oversight to medical device data systems (MDDS), medical image storage devices, and medical image communication devices. FDA does not intend to enforce the requirements of the Federal Food, Drug, and Cosmetic Act for hardware functions that are considered to be MDDS, medical image storage devices, or medical image communication devices, provided that the hardware function is limited to assisting the following software functions: electronic transfer, storage, conversion of formats, or display of medical device data and results. Software functions that are solely intended to transfer, store, convert formats, or display medical device data and results, including medical images, waveforms, signals, or other clinical information, are not devices and are not subject to applicable FDA regulatory requirements.

This guidance was revised through a minor update to reflect amended medical device classification regulations following the issuance of the final rule, “Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act” (86 FR 20278). 

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