June 30, 2014 by MassDevice
By Yarmela Pavlovic and Jennifer Henderson
In a 20 June 2014 draft guidance, the Food and Drug Administration (FDA or Agency) proposed that, once the guidance is finalized, the Agency would refrain from enforcement of all regulatory requirements for a subset of hardware and software that transfers, stores, converts, formats, and displays medical device data or medical imaging data, which would include Medical Device Data Systems (MDDS), Medical Image Storage (MIS) devices, and Medical Image Communications (MIC) devices. The draft guidance titledMedical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (Draft Guidance), informs manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with applicable regulatory controls for these products. The Draft Guidance also proposes conforming changes to its Mobile Medical Applications guidance released earlier this year.
Under the current regulatory regime, the FDA classifies each of the following as class I medical devices:
