Welcome to today’s 

FDA/CDRH Webinar

Thank you for your patience while additional time is 

provided for participants to join the call. 

Please connect to the audio portion of the webinar 

now: 

U.S. Callers: 888-780-9649 

International Callers:1-630-395-0306 

Conference Number: PWXW9584733

Passcode: 2179630 
Changes to Existing Medical Software 

Policies Resulting from Section 3060 of 

the 21st Century Cures Act

Matthew Diamond, MD, PhD

Medical Officer

Division of Digital Health

Office of Strategic Partnerships and Technology Innovation

Center for Devices and Radiological Health

November 14, 2019
3

Agenda

• Background

• Summary of Final Guidance and Updates to Existing Guidances

• Questions and Answers
4

Functionality Focused Approach to Software

Risk Based 

Functionality 

Focused

Platform 

Independent

Promote 

Innovation

Narrowly 

Tailored

Promote 

Patient 

Engagement

Protect 

Patient 

Safety
5

Recognition of low risk

Digital Health products 

21st Century Cures Act:

Building on FDA’s Digital Health Policy

Codification of existing 

enforcement discretion 

policies

Applying a least 

burdensome approach for 

device regulation
6

• Final guidance “Changes to Existing Medical Software Policies 

Resulting from Section 3060 of the 21st Century Cures Act” 

(“3060 Guidance”)

• Provides FDA’s current thinking regarding the amended device definition and the 

resulting effect the amended definition has on FDA’s guidances related to medical device 

software. 

21st Century Cures Act

• 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
7

21st Century Cures Act (Section 3060) and FDA Policies

Amended the definition of “device” in the Federal 

Food, Drug, and Cosmetic Act to exclude certain 

software functions intended for...

FDA policies 

affected/codified

Administrative Functionality

(B) General Wellness;

(C) Electronic Patient Records

(D) Transfer, Store, Convert formats, 

Display related information; 

(E) Clinical Decision Support

(A) Administrative support;

FDA Policy for Low-Risk General 

Wellness Products

Health Management Functionality

Policy for Clinical Decision 

Support Software included in 

Health Management Functionality

Medical Device 

Data System 

(MDDS)

Confidential/Pre-decisional/Deliberative

*Addition of 520(o)(2) describes the regulation and assessment of a software product with multiple functions
8

Objectives

• Present what software functions were excluded from the 

device definition by the 21st Century Cures Act (Cures Act)

• Explain how FDA’s existing software guidances have been 

updated to reflect the change to the device definition
9

• Defines software functions that are not devices

• States that the FDA shall not regulate non-device functions of a product with multiple 

functions – but can consider the impact of non-device functions on the device functions

• Provides for the FDA regulation of software functions that are excluded from the device 

definition by the Cures Act, if the FDA finds that it would be reasonably likely to have 

serious adverse health consequences (substantive and procedural criteria must be met)

• Exclusions from device definition do not include software used in the manufacture and 

transfusion of blood and blood components to assist in the prevention of disease in humans

• A software function may also not be excluded from the definition of a device if it is found that 

the use of such software function would be reasonably likely to have serious adverse health 

consequences and the software function has been identified by a final order

Overview of Cures Act Software Provisions 

(Section 3060)
10

• 3060 Guidance describes changes that will be made through concurrent 

Level 2 updates to existing software guidances, including:

– Mobile Medical Applications (MMA)

– General Wellness: Policy for Low Risk Devices

– Medical Device Data Systems, Medical Image Storage Devices, and 

Medical Image Communications Devices (MDDS)

– Off-the-Shelf Software Use in Medical Devices

– Guidance for the Submission of Premarket Notifications for Medical 

Image Management Devices

Corresponding Changes Reflected 

in Other Guidance Documents
11

Draft 3060 Guidance Changes from Draft: 

• Software functions intended for 

administrative support of a health care 

facility are not devices

• Maintenance of financial records,

• Information about patient 

populations, 

• Laboratory workflow, etc.

No Change in policy

• Clarified that certain Laboratory 

Information Systems (LIS) include 

software functions that remain 

device

Administrative Functions: FDA generally did not consider devices (520(o)(1)(A) of FD&C Act)

Differences Between the Draft and Final Guidance
12

• General wellness (GW) products that 

maintain or encourage a “general state of 

health or healthy activity” - Excluded from 

Device definition 

• GW products with intended use related to 

helping reduce the risk or impact of certain 

chronic diseases or conditions” – Not 

excluded from Device definition, but the 

FDA continues not to intend to enforce 

compliance with applicable regulations

No Change in policy

• Clarified how the two GW 

categories are 

affected/unaffected by Cures; 

• Noted that hardware 

products that fit the first 

category are not excluded 

from the device definition 

(but remain under 

enforcement discretion)

General Wellness: Policy for Low Risk Devices (520(o)(1)(B) of FD&C Act)

Differences Between the Draft and Final Guidance

Draft 3060 Guidance Changes from Draft: 
13

The General Wellness Guidance defines two categories of general 

wellness intended uses:

Category 1. An intended use that relates to maintaining 

or encouraging a general state of health or a healthy 

activity

Category 2. An intended use that relates the role of healthy

lifestyle with helping to reduce the risk or impact of 

certain chronic diseases or conditions and where it is 

well understood and accepted that healthy lifestyle 

choices may play an important role in health 

outcomes for the disease or condition

General Wellness Intended Uses
14

• Software functions for maintaining or encouraging a healthy 

lifestyle are now excluded from the device definition per the 

Cures Act –

– As long as the software function is unrelated to the 

diagnosis, cure, mitigation, prevention, or treatment of a 

disease or condition. 

• Hardware with general wellness intended uses that meet the 

device definition remain devices, but FDA does not intend to 

enforce compliance with the regulatory controls for such 

devices. Refer to the revised General Wellness guidance for 

FDA’s current thinking on these products. 

General Wellness Intended Use: Category 1
15

• If the intended use relates the role of healthy lifestyle with 

helping to reduce the risk or impact of certain chronic diseases 

or conditions and where it is well understood and accepted that 

healthy lifestyle choices may play an important role in health 

outcomes for the disease or condition, then the product is not 

excluded from the definition of the term “device.”

• Refer to the revised General Wellness guidance for current 

policy.

General Wellness Intended Use: Category 2
16

Draft 3060 Guidance Changes from Draft: 

• For the record to be excluded from the 

device definition it must 

• Be created/reviewed by HCPs, 

• Certified under ONC Health IT 

Certification Program, and 

• Not intended for interpretation or 

analysis for the purpose of diagnosis, 

cure, mitigation, prevention, or 

treatment of a disease or condition

• FDA does not intend to enforce the 

requirements for records that are not 

certified under the ONC Health IT 

Certification Program

• Personal health records (not 

created/reviewed by HCPs) are not devices 

No Change in policy

• Created sections to describe 

each of exclusion criteria

• Added examples as requested 

by comments

Electronic Patient Records: (520(o)(1)(C) of FD&C Act)

Differences Between the Draft and Final Guidance
17

• Software functions that transfer, store, convert 

formats, and display device data and results describe 

functions included in the Medical Device Data Systems 

(MDDS) regulations and MDDS guidance

• MDDS functions were under enforcement discretion 

per MDDS guidance 

• MDDS guidance did not distinguish between 

hardware and software functions

• MDDS regulation includes both hardware and 

software in the identification

• Included reference to our policy for alarms/alerts/flags, 

because MDDS regulation refers to active patient 

monitoring

• Clarifies that only software MDDS 

functions are excluded from device 

definition

• MDDS hardware remains under 

enforcement discretion (except 

specialized medical display 

hardware)

• Clarifies that software MDDS functions 

are excluded from the device definition 

whether or not they are intended for active 

patient monitoring

• Refers to Clinical Decision Support (CDS) 

draft guidance for discussion of alarms/ 

alerts/ flags

• CDS draft guidance describes alarms/ 

alerts/ flags as device functions (they 

analyze medical device data, so are 

not excluded per 520(o)(1)(E) “1st 

criterion”)

Transfer, Store, Convert Formats, Display Data and Results: (520(o)(1)(D) of FD&C Act)

Draft 3060 Guidance Changes from Draft: 

Differences Between the Draft and Final Guidance
18

• Software functions that are solely intended to transfer, store, 

convert formats, and display medical device data or results, are now 

excluded from the device definition per the Cures Act and 

considered Non-Device-MDDS.

– These non-device software functions may or may not be intended 

for active patient monitoring.

– Software functions intended to interpret or analyze clinical 

laboratory test or other device data, results, and findings are not 

considered MDDS and are not excluded from the device definition.

MDDS Guidance: Software Functions
19

• Hardware products that are solely intended to transfer, store, 

convert formats, and display medical device data or results are 

considered Device-MDDS, but 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.

• Specialized medical display hardware devices, e.g. for digital 

mammography, radiology, pathology, and ophthalmology have NOT 

been considered Device-MDDS and are NOT excluded from the 

device definition by the Cures Act.

MDDS Guidance: Hardware
20

• Software functions and hardware products that are NOT intended 

by the manufacturer for a device function under 201(h) of the FD&C 

Act, e.g. general purpose hardware IT infrastructure intended for data 

transfer (e.g. network router), data storage (e.g. network storage 

(NAS)), conversion of data (e.g. PDF software), and display of data 

(computer monitor) do not meet the definition of a device for either 

the software or hardware functions and therefore are not regulated 

as devices.

MDDS Guidance: General Purpose Products
21

• Where the previous guidance referred to “mobile application,” the 

new guidance refers to “software function.” 

• Several examples from Appendix B (enforcement discretion) have 

been moved to Appendix A (not medical devices). 

– Including General Wellness, Electronic Patient Records, and 

MDDS functions.

• Examples in Appendix C (regulatory oversight) have been revised.

Changes to MMA Guidance
22

• Section 3.2.2 titled, “Exemption of Laboratory Information 

Management Systems,” has been removed from the 

guidance. 

– Section is specific to Laboratory Information Systems 

(LIS) and Laboratory Information Management Systems 

(LIMS). 

• Some terminology and citations updated. 

Changes to Off-the-Shelf Software Guidance
23

• Guidance withdrawn because some software functions 

described in the guidance no longer meet the definition of 

a device, as amended. 

– For the limited subset of Medical Image Management 

Devices that continue to meet the definition of a device, 

CDRH encourages manufacturers to reference the most 

recent FDA-recognized versions of relevant voluntary 

consensus standards instead. 

Medical Image Management Devices Guidance
24

Stakeholder feedback requested on the revised Draft Guidance: 

Clinical Decision Support Software

(https://www.fda.gov/regulatory-information/search-fda-guidancedocuments/clinical-decision-support-software)

• In response to comments, FDA adopted risk-based approach to 

regulation of Device CDS informed by the International Medical Device 

Regulators Forum (IMDRF) Framework

• No longer proposing to use a separate category for Patient Decision 

Support Software

• Clarifying interpretation of Cures criteria for exclusion from device 

definition

Open for comment until December 26, 2019 at www.regulations.gov

under docket number FDA-2017-D-6569

Stakeholder Feedback Requested
25

Guidance documents discussed in this webinar: 

• Changes to Existing Medical Software Policies Resulting from 

Section 3060 of the 21st Century Cures Act

• Policy for Device Software Functions and Mobile Medical 

Applications (originally titled Mobile Medical Applications)

• General Wellness: Policy for Low Risk Devices

• Off-The-Shelf Software Use in Medical Devices

• Medical Device Data Systems, Medical Image Storage Devices, and 

Medical Image Communications Devices

Sign Up to get Digital Health email updates: 

https://www.fda.gov/medical-devices/digital-health

Resources
26

For Digital Health questions: digitalhealth@fda.hhs.gov

Division of Industry and Consumer Education: DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading: Specialty Technical Topics; Subheading: IT and Software

Questions?