Step 5: Is the Software Function Intended For Transferring, Storing, Converting Formats, or Displaying Data and Results?
Intercommunication between medical devices and health information technology is facilitated by hardware and software that is typically referred to as medical device data systems (MDDS). Software functions that are solely intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results are not medical devices. The FDA has referred to these software functions as Non-Device-MDDS.
Step 5 will help determine if your MDDS software function is a device.
5.A: Is the software function SOLELY intended to transfer, store, convert formats, or display medical device data and results, including medical images, waveforms, signals, or other clinical information?
Continue to Question 5.B.
Your product may be a device. Go to Step 6.
WHY: If your software function includes any other functions beyond the transfer, storage, conversion of formats, or display of medical device data, then it may be a device. Only 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 the FDA's regulatory requirements applicable to devices.
LEARN: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
5.B: Does the software function control or alter the functions or parameters of any connected medical device?
Your product may be a device. Go to Step 6.
WHY: Non-Device-MDDS software functions do not control or alter the functions or parameters of any connected medical devices, as described in the FDA guidance, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices. Answering "Yes" to Question 5.B suggests the software function is not excluded from the device definition by section 520(o)(1)(D) of the FD&C Act. The software function may be the focus of the FDA's regulatory oversight as a device.
LEARN: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
Continue to Question 5.C.
5.C: Does the software function generate alarms or alerts or prioritize patient-related information on multi-patient displays, or provide for active patient monitoring to enable immediate clinical action?
Your product may be a device. Go to Step 6.
WHY: As described in the FDA guidance, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices, Non-Device-MDDS software functions are not intended to generate alarms or alerts or prioritize patient-related information on multi-patient displays. Software functions intended to generate alarms or alerts or prioritize patient-related information on multi-patient displays, which are typically used for active patient monitoring, are device software functions because these functions involve analysis or interpretation of laboratory test or other device data and results. Software functions that are device functions intended for active patient monitoring to enable immediate awareness for potential clinical intervention include the following characteristics:
- The clinical context requires a timely response (for example, in-hospital patient monitoring).
- The clinical condition (disease or diagnosis) requires a timely response (for example, a monitor that is intended to detect life-threatening arrhythmias, such as ventricular fibrillation, or a device used to actively monitor diabetes for time-sensitive intervention).
Answering "Yes" to Question 5.C suggests the software function is not excluded from the device definition by section 520(o)(1)(D) of the FD&C Act. The software function may be a focus of the FDA's regulatory oversight as a device.
LEARN: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
Continue to Question 5.D.
5.D: Does the software function analyze or interpret medical device data?
Your product may be a device. Go to Step 6.
WHY: Software functions that analyze or interpret medical device data in addition to transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results remain subject to the FDA's regulatory oversight, unless they meet the criteria outlined in section 520(o)(1)(E) of the FD&C Act. Answering "Yes" to Question 5.E suggests the software function is not excluded from the device definition by section 520(o)(1)(D) of the FD&C Act. The software function may be the focus of the FDA's regulatory oversight as a device. Continue to Step 6 to learn more about section 520(o)(1)(E) of the FD&C Act.
LEARN: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
LIKELY NOT A DEVICE
The Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program provides assurance to purchasers and other users that a system meets the technological capability, functionality, and security requirements adopted by the Department of Health and Human Services (HHS).
WHY: The software function likely meets the definition of Non-Device-MDDS, as described in the FDA guidance, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices and the criteria described in section 520(o)(1)(D) of the FD&C Act, which states thatthe term device, as defined in section 201(h), shall not include a software function that is intended "for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings." Considering your answers to the previous questions, answering "No" to Question 5.D suggests the software function may not meet the device definition.
If you are unsure, go to Step 6 to learn about other device criteria and considerations that may apply to your software function.
LEARN: Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices; Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
ASK: If you have questions or would like feedback, go to Resources to learn about engaging with the FDA or email the Digital Health inbox.
If your product contains another software function, go to Step 1 for the next software function.
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