Contains Nonbinding Recommendations
Medical Device Data Systems, Medical 
Image Storage Devices, and Medical 
Image Communications Devices 
Guidance for Industry and
Food and Drug Administration Staff
Document issued on September 28, 2022.
Document originally issued on February 9, 2015.
For questions about this document regarding CDRH-regulated devices, contact the Digital Health 
Center of Excellence by email at digitalhealth@fda.hhs.gov. For questions about this document 
regarding CBER-regulated devices, contact the Office of Communication, Outreach, and 
Development (OCOD) at 1-800-835-4709 or 240-402-8010, or by email at ocod@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2014-D-0798. Comments may not be acted 
upon by the Agency until the document is next revised or updated.
Additional Copies
CDRH
Additional copies are available from the Internet. You may also send an email request to CDRH-
Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 
1400021 and complete title of the guidance in the request.
CBER
Additional copies are available from the Center for Biologics Evaluation and Research (CBER), 
Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave., 
WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-4709 or 240-402-8010, 
by email, ocod@fda.hhs.gov, or from the Internet at 
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances.  Contains Nonbinding Recommendations
Table of Contents
I.  Introduction ....................................................................................................................... 4
II.  Background ....................................................................................................................... 4
III.  Definitions ......................................................................................................................... 5
IV.  Policy for Non-Device-MDDS and Device-MDDS .......................................................... 6
A.  Policy for Non-Device-MDDS......................................................................................... 6
B.  Policy for Device-MDDS ................................................................................................. 8
C.  Multiple Function Device Products that contain MDDS ................................................. 9 Contains Nonbinding Recommendations
Medical Device Data Systems, Medical 
Image Storage Devices, and Medical 
Image Communications Devices
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page. 
I.  Introduction
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 inter-
communication 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 FDAs 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.
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidances means that something is suggested or recommended, 
but  not required.
II.  Background
On February 15, 2011, FDA issued a regulation down-classifying MDDS from Class III (high-
risk) to Class I (low-risk) (MDDS regulation).1 Since down-classifying MDDS, FDA has 
gained additional experience with these types of technologies, and has determined that these 
1 See the final rule Medical Devices; Medical Device Data Systems (76 FR 8637) at 
https://www.federalregister.gov/documents/2011/02/15/2011-3321/medical-devices-medical-device-data-systems.
4 Contains Nonbinding Recommendations
devices pose a low risk to the public. On February 9, 2015, FDA issued a guidance document to 
inform manufacturers, distributors, and other entities that the Agency does not intend to enforce 
compliance with the regulatory controls that apply to MDDS, medical image storage devices, 
and medical image communications devices, due to the low risk they pose to patients and the 
importance they play in advancing digital health.
Since the issuance of the guidance document in 2015, section 3060(a) of the 21st Century Cures 
Act (Cures Act) amended section 520 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
on December 13, 2016, removing certain software functions from the definition of device in 
section 201(h) of the FD&C Act. Specifically, pursuant to section 520(o)(1)(D) of the FD&C 
Act, software functions that are solely intended to transfer, store, convert formats, or 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. On September 27, 2019, this 
guidance was previously revised through a minor update in accordance with the Cures Act, with 
the changes described in the guidance Changes to Existing Medical Software Policies Resulting 
from Section 3060 of the 21st Century Cures Act.2 The policy described in this guidance 
document is also consistent with the Agencys updated guidance, also revised through a minor 
update on September 27, 2019, entitled Policy for Device Software Functions and Mobile 
Medical Applications, originally issued on February 9, 2015, with the title Mobile Medical 
Applications.3
This guidance is being now revised through a minor update to be consistent with the final rule 
Medical Devices; Medical Device Classification Regulations To Conform to Medical Software 
Provisions in the 21st Century Cures Act (86 FR 20278, April 19, 2021).4 This rule amended 
certain medical device classification regulations to reflect changes in the FD&C Act made by the 
Cures Act, as described above. FDA amended these medical device classification regulations so 
that our regulations conform to the medical software provisions in the Cures Act. This latest 
revision also includes minor changes to address comments submitted to the docket. This 
guidance reflects FDAs current thinking on the definitions of MDDS, medical image storage 
devices, and medical image communications devices.
III.  Definitions
The following terms are used for the purposes of this guidance: 
Non-Device-MDDS: Software functions that are solely intended to transfer, store, 
convert formats, or display medical device data and results.
2 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/changes-existing-
medical-software-policies-resulting-section-3060-21st-century-cures-act.
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-
functions-and-mobile-medical-applications.
4 See 86 FR 20278 at https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-
device-classification-regulations-to-conform-to-medical-software-provisions.
5 Contains Nonbinding Recommendations
Device-MDDS: Hardware functions that are solely intended to transfer, store, convert 
formats, or display medical device data and results.
IV.  Policy for NonDeviceMDDS and DeviceMDDS
A.  Policy for NonDeviceMDDS
Software functions that meet the definition of Non-Device-MDDS, medical image storage 
devices, or medical image communications devices are not devices under section 201(h) of the 
FD&C Act. As such, 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 thus are not subject to FDA regulatory 
requirements applicable to devices. However, 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 FDAs regulatory oversight 
unless they meet the criteria outlined in section 520(o)(1)(E) of the FD&C Act.
FDA further clarifies the Non-Device-MDDS policy through the following examples: 
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:5
 The electronic transfer or exchange of medical device data. For example, this would 
include software that collects output from a ventilator about a patients 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.
5 As noted in the preamble of the MDDS regulation, the word active represents any device that is intended to be 
relied upon in deciding to take immediate clinical action (76 FR 8637 at 8644). FDA further noted that there are 
existing classifications for patient monitoring devices (See, e.g., 21 CFR Part 880, Subpart C (general hospital and 
personal use monitoring devices); 21 CFR Part 868, Subpart C (anesthesiology monitoring devices); 21 CFR Part 
884, Subpart C (obstetrical and gynecological monitoring devices); and 21 CFR Part 870, Subpart C (cardiovascular 
monitoring devices)).
6 Contains Nonbinding Recommendations
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 multi-
patient 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 childs 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-Device-
MDDS.
7 Contains Nonbinding Recommendations
 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 Non-
Device-MDDS functionality.
B.  Policy for DeviceMDDS 
Hardware functions that are intended to transfer, store, convert formats, or display medical 
device data and results remain devicesunder section 201(h) of the FD&C Act. FDAdoes not 
intend to enforce the requirements under the FD&C Act for hardware functions that are 
considered to be Device-MDDS, medical image storagedevices, 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 includethe 
following regulations:
a) MDDS subject to 21 CFR 880.6310,6
b)  Medical image storage devices subject to 21 CFR 892.2010,7and
c)  Medical image communications devices subject to 21 CFR 892.2020.8
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) 
6 Available at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-880/subpart-G/section-880.6310.
7 Available at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-892/subpart-B/section-892.2010. 
8 Available at https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-892/subpart-B/section-892.2020.
8 Contains Nonbinding Recommendations
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. 
In some cases, software functions that transfer, store, convert formats, or display medical device 
data and results are utilized on hardware that is not intended by the hardware manufacturer for a 
device function under section 201(h) of the FD&C Act. For example, general-purpose hardware 
IT infrastructure intended for data transfer (e.g., network router), data storage (e.g., network 
attached storage (NAS)), conversion of data (e.g., PDF software), and display of data (computer 
monitor) are not device functions. Such products do not meet the definition of a device in section 
201(h) of the FD&C Act for either the software or hardware function and are therefore not 
regulated as devices.
C.  Multiple Function Device Products that contain 
MDDS
Consistent with section 520(o)(2) of the FD&C Act, which describes the regulation of a product 
with multiple functions, including at least one device function and at least one software function 
that is not a device, FDA does not regulate the Non-Device-MDDS functions contained in a 
multiple function device product. If a multiple function device product contains Device-MDDS 
functions, FDA does not, at this time and based on our current understanding of the risks of these 
devices, intend to enforce the requirements under the FD&C Act. However, FDA may assess the 
impact that such Non-Device-MDDS and Device-MDDS functions have on the safety and 
effectiveness of the device function(s) in the multiple function device product. FDAs 
recommendations on the regulation of such products with multiple functions is provided in the 
guidance Multiple Function Device Products: Policy and Considerations.9
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-function-
device-products-policy-and-considerations.
9