FDA Guidance for Medical Device Data Systems, MedicalImage Storage Devices, and Medical Image Device
October 28 2022
The Food and Drug Administration (FDA) recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such intercommunication is hardware and software, typically referred to as medical device data systems (MDDS) that transfer, store, convert formats, or display medical device data and results. This guidance provides FDA’s current thinking for MDDS, as well as medical image storage devices and medical image communications devices, to provide clarity and predictability for manufacturers on these devices.
FDA Regulation : NonDeviceMDDS and DeviceMDDS
Software functions that are solely intended to transfer, store, convert formats, or display medical device data and results.
A Non-Device-MDDS is a software function solely intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices, which may or may not be intended for active patient monitoring:
The electronic transfer or exchange of medical device data. For example, this would include software that collects output from a ventilator about a patient’s carbon dioxide level and transmits the information to a central patient data repository.
The electronic storage and retrieval of medical device data. For example, software that stores historical blood pressure information for later review by a health care provider.
The electronic conversion of medical device data from one format to another in accordance with a preset specification. For example, software that converts digital data generated by a pulse oximeter into a digital format that can be printed.
The electronic display of medical device data, which may include certain secondary or remote displays to medical devices that solely display data and results. For example, software that displays a previously stored electrocardiogram for a particular patient.
Non-Device-MDDS do not modify the data, do not control the functions or parameters of any connected medical device, and do not analyze or interpret data. Software functions intended to generate alarms or alerts or prioritize patient-related information on multipatient displays, which are typically used for active patient monitoring, are considered device software functions because these functions involve analysis or interpretation of laboratory test or other device data and results. As noted above, a Non-Device-MDDS may include software functions that transfer, store, convert formats, or display medical device data that may or may not be intended for active patient monitoring.
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 (e.g., in-hospital patient monitoring).
The clinical condition (disease or diagnosis) requires a timely response (e.g., 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).
Examples of devices that provide active patient monitoring include:
A nurse telemetry station that functions as a secondary alarm system that receives and displays information from a bedside hospital monitor in an intensive care unit (ICU) to enable immediate awareness for potential clinical intervention.
A device that receives and/or displays information, alarms, or alerts from a monitoring device in a home setting and is intended to alert a caregiver to take an immediate clinical action.
Examples of software functions that transfer, store, convert formats, or display medical device data and are Non-Device-MDDS:
An application that transmits a child’s temperature to a parent/guardian while the child is in the nurse/health room of a school.
An application that facilitates the remote display of information from a blood glucose meter, where the user of the meter can independently review their glucose and glucose levels, and which is not intended to be used for taking immediate clinical action. In these cases, remotely displaying information such as the most recent blood glucose value or time-lapse between blood glucose measurements is not considered active patient monitoring.
Any assemblage or arrangement of network components that includes specialized software expressly created for a purpose consistent with the definition of Non-DeviceMDDS.
Custom software that is written by entities other than the original medical device manufacturer (e.g., hospitals, health care providers, third party vendors) that directly connects to a medical device solely to obtain medical device information.
Modified portions of software that are part of an Information Technology (IT) infrastructure created and/or modified (writing and compiling software) for specific NonDevice-MDDS functionality.
Hardware functions that are intended to transfer, store, convert formats, or display medical device data and results remain devices under section 201(h) of the FD&C Act. FDA does not intend to enforce the requirements under the FD&C Act for hardware functions that are considered to be Device-MDDS, medical image storage devices, or medical image communications 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. Device-MDDS do not modify the data and do not control the functions or parameters of any connected medical device.
These hardware functions may include the following regulations:
MDDS subject to 21 CFR 880.6310
Medical image storage devices subject to 21 CFR 892.2010
Medical image communications devices subject to 21 CFR 892.2020
This means that for hardware functions that meet the definitions in the regulations listed above, FDA does not intend to enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting, and quality system regulation for manufacturers of these types of devices.
Each Device-MDDS regulation listed above contains an exemption from premarket notification; however, limitations to this exemption identified under 21 CFR 880.9 and 21 CFR 892.9 require a premarket notification in the listed circumstances. Even when exceeding these limitations, FDA does not intend to enforce compliance with the regulatory controls for hardware functions that meet the definitions identified by the above regulations. For example, to the extent that these limitations apply, FDA does not intend to enforce compliance with regulatory controls for a Device-MDDS that is an in vitro device that is intended for assessing the risk of cardiovascular diseases (21 CFR 880.9(c)(4)) or for use in diabetes management (21 CFR 880.9(c)(5)).
Specialized medical display hardware devices for digital mammography, radiology, pathology, and ophthalmology (see, for example, 21 CFR 892.2050) and other specialized medical display hardware integral to the safe and effective use of a medical device hardware product (such as integral 3D displays in robotic surgery systems and displays built into ICU bedside monitors) have not been considered MDDS, medical image storage devices, or medical image communications devices. Such medical display hardware devices and other specialized medical display hardware integral to a medical device are not excluded from the device definition by the Cures Act and are not considered to be Device-MDDS.
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