Software for medical devices

Medical device software update from FDA

New Guidance: Medical Device Data System and Medical Image Storage (CDRH & CBER)

What do you need to know?

Pursuant to section 520(o)(1)(D) of the FD&C Act, software functions that are solely intended to transfer, store, convert formats, and display medical device data or medical imaging data, unless the software function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings, are not devices and are not subject to FDA laws and regulations applicable to devices.

Hardware products that are intended to transfer, store, convert formats, and display medical device data and results remain devices under section 201(h) of the FD&C Act. FDA does not intend to enforce compliance with the regulatory controls for such 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.

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Guidance for Industry and Food and Drug Administration Staff SEPTEMBER 2019


Download the Full FDA Guidance Document Here: