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02/24/2015 1
Webinar Objective

• Share CDRH’s perspective and approach on Digital 

health guidance's

• Clarify Final MDDS guidance and the updated Final 

Mobile Medical Apps guidance

• Clarify our proposal in the Draft guidance and solicit 

public comments

02/24/2015 2
Digital Health

3

Bakul Patel

Associate Director for Digital Health

Office of Center Director 

Center for Devices and Radiological Health

02/24/2015
Overview

4

• a patient and innovation focused approach CDRH’s vision 

and approach 

Mobile apps • a narrowly tailored and focused approach

• Promoting connectivity and interoperability MDDS 

guidance

• Proposed approach for “General Wellness” 

and “Medical Device Accessories”

Draft 

guidance's

02/24/2015
5

• Patients in the U.S. have access to highquality, safe, and effective medical devices of 

public health importance first in the world. 

• The U.S. is the world’s leader in regulatory 

science, medical device innovation and 

manufacturing, and radiation-emitting product 

safety. 

• U.S. post-market surveillance quickly identifies 

poorly performing devices, accurately 

characterizes real-world performance, and 

facilitates device approval or clearance. 

• Devices are legally marketed in the U.S. and 

remain safe, effective, and of high-quality. 

• Consumers, patients, their caregivers, and 

providers have access to understandable 

science-based information about medical 

devices and use this information to make health 

care decisions. 

Vision

02/24/2015
Oversight Approach

Risk based

Functionality 

focused

Platform 

independent

Promote 

innovation

Narrowly 

tailored

Promote 

patient 

engagement

Protect 

patient 

safety

02/24/2015 6
Functionality Focused Oversight

• Focuses only on traditionally 

regulated functionality

– Cleared, approved or otherwise 

regulated

• Provides users with same level 

of assurance of patient safety

• Identifies type of apps that FDA 

does not intend to enforce 

requirements

• Clarifies what is not a device –

(Outside of FDA’s Jurisdiction)

7

Mobile apps not 

considered 

“medical devices”

MMA

Lower 

Risk mobile apps 

that meet “device” 

Definition but not 

considered “MMA” 

02/24/2015
Mobile Medical Apps (MMA)

No regulatory 

requirements

• Patient self-management apps

• Tools to organize and track their health 

information (not for treating or adjusting 

medications)

• Tools to access to health information document 

and communicate with health care providers

• Tools that automate simple health care 

providers tasks

Enforcement Discretion

Mobile apps not 

considered 

“medical devices”

MMA

Lower risk 

mobile apps that

meet “device” definition

but not considered “MMA” 

Mobile apps that meet “device” 

definition that are either intended

• To be used as an accessory to 

already regulated medical device, 

or

• To transform a mobile platform 

into a regulated medical device.

focus of 

oversight

02/24/2015 8
Mobile medical apps (MMA)

“mobile medical app” is a mobile app that meets the definition of 

device in section 201(h) of the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) ; and either is intended: 

– to be used as an accessory to a regulated medical device; or

– to transform a mobile platform into a regulated medical device

Examples in Section V-A + Appendix C

9

MMA

focus of

oversight

02/24/2015
Mobile Medical Apps

1. Mobile apps that are an extension of one or more medical 

devices by connecting to such device(s) for purposes of 

controlling the device(s) or displaying, storing, analyzing, or 

transmitting patient-specific medical device data. 

2. Mobile apps that transform the mobile platform into a 

regulated medical device by using attachments, display 

screens, or sensors or by including functionalities similar to 

those of currently regulated medical devices. 

3. Mobile apps that become a regulated medical device (software) 

by performing patient-specific analysis and providing patientspecific diagnosis, or treatment recommendations. 

02/24/2015 10
Mobile Apps –(not considered MMA)

Mobile apps –

NOT Medical Devices

• Library of clinical descriptions

• Medical flash cards 

• Certification or recertification preparation 

apps;

• Games to train health professionals in 

advanced CPR skills.

• Allow users to input pill shape, color or 

imprint and displays pictures and names of 

pills that match this description;

• Find the closest medical facilities;

• Help guide patients to ask appropriate 

questions to their physician 

• Track, review and pay medical claims and 

bills online;

• Manage or schedule hospital rooms or bed 

space

Mobile apps –

NOT Focus of Oversight

• Help patients (i.e., users) self-manage their 

disease or conditions without providing 

specific treatment or treatment suggestions; 

• Provide patients with simple tools to 

organize and track their health information; 

• Provide easy access to information related to 

patients’ health conditions or treatments; 

• Help patients document, show, or 

communicate potential medical conditions to 

health care providers; 

• Automate simple tasks for health care 

providers; or 

• Enable patients or providers to interact with 

Personal Health Record (PHR) or Electronic 

Health Record (EHR) systems.

02/24/2015 11
FDASIA Health IT Report

12

Public and workgroup feedback

• Agencies should address 

ambiguities 

• Agencies should reevaluate 

current regulation

Proposed further Clarity on

• Distinction between wellness 

and disease-related claims 

• Medical device accessories 

02/24/2015
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Final MDDS Rule 

(§ 21 CFR 880.6310) Feb 15, 2011

... intended to provide one or more of the following uses, without 

controlling or altering the functions or parameters of any 

connected medical devices:

(i) The electronic transfer of medical device data;

(ii) The electronic storage of medical device data;

(iii) The electronic conversion of medical device data from one format to 

another format in accordance with a preset specification; or

(iv) The electronic display of medical device data. 

• Does not include devices intended to be used in connection with 

active patient monitoring.

Federal Register / Vol. 76, No. 31 -- http://www.gpo.gov/fdsys/pkg/FR-2011-02-15/pdf/2011-3321.pdf

02/24/2015
Revaluating Current Regulations

• MDDS and medical Image storage and communication device

– Generally were considered lower risk - class I

– Systems that record, share, and use of medical device data have 

become a significant in a connected healthcare system

– These inter-communication functionality is foundational in an 

interoperable digital health ecosystem.

• Proposed draft guidance (June 2014) intended to 

– Provide continued clarity in Digital Health

– Narrowly focus on higher risk products

– Create and impetus for devices to share data and ultimately 

become interoperable with other systems

02/24/2015 14
Public feedback

• Majority of the comments indicated the following:

– Supported the deregulatory policy for MDDS

– Suggested specific edits to the language to clarify

– Asked to clarifying the exclusion criteria of “active patient 

monitoring” that would make products to be NOT considered MDDS 

– Asked to supplement the final guidance with permanent regulations

• In response to the feedback - the final guidance :

– Maintains the proposed policy without any changes

– Added additional language in the background section from the published 

final MDDS rule –

• added definition of the MDDS from the published rule

• Added clarifying language, primarily from the preamble of the MDDS rule 

related “active patient monitoring”

– Made the edits as proposed to MMA guidance to reflect MDDS policy

02/24/2015 15
MDDS Final Guidance (Feb 9, 2015)

The FDA does not intend to 

enforce compliance with the 

regulatory controls that apply 

to the following devices: 

• MDDS subject to 21 CFR 

880.6310, 

• Medical image storage devices 

subject to 21 CFR 892.2010, 

and 

• Medical image 

communications devices 

subject to 21 CFR 892.2020. 

MDDS does not include --

A. Products that are intended 

for active patient 

monitoring i.e. 

– clinical context requires a 

timely response 

– The clinical condition (disease 

or diagnosis) requires a timely 

response 

B. Modifies the medical device 

data, and 

C. Control the functions or 

parameters of any 

connected medical device.

02/24/2015 16
Updated MMA Guidance 

(notable changes) (Feb 9, 2015)

Mobile Medical Apps

Further narrows apps defined as 

MMA ...

• Mobile apps that are an 

extension of one or more 

medical devices by connecting 

to such device(s) for purposes 

of controlling the device(s) or 

for use in active patient 

monitoring or displaying, 

storing, analyzing, or 

transmitting patient-specific

medical device data. 

Mobile apps under enforcement 

Discretion

Includes

• MDDS -- Intended to transfer, 

store, convert format, and 

display medical device data in 

its original format from a 

medical device (as defined by 

MDDS regulation 880.6310 

OUG).

• Examples previously added to 

website

02/24/2015 17
Addressing evolving Mobile apps 

landscape

• Web page for mobile medical apps

– http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/

ConnectedHealth/MobileMedicalApplications/default.htm

• FDA, on this website intends to have a list of

– example types that we intend to exercise enforcement discretion, 

regulate or have considered not devices.

• Provide internal coordination to maintain consistent policy decisions 

related to mobile medical apps

• Questions related to mobile medical apps –

MobileMedicalApps@fda.hhs.gov

02/24/2015 18
Draft General Wellness guidance –

Policy for Low Risk devices 

PROPOSES A POLICY THAT

- Does not intend to examine low risk general wellness products to determine 

whether they are “devices” within the meaning of the FD&C Act, or 

- If they are “devices”, FDA does not intend to enforce compliance to 

regulatory requirements for devices under the FD&C Act

PRODUCTS COVERED UNDER THE PROPOSED POLICY

A. Products intended for only general wellness use, and 

B. Products inherently present a very low risk to users’ safety.

q PRODUCTS INTENDED FOR GENERAL WELLNESS USE CAN BE MARKETED 

q without any reference to diseases or conditions, or 

q with a disease-related general wellness claims that contain references 

where it is well understood that healthy lifestyle choices may reduce 

the risk or impact of a chronic disease or medical condition.

02/24/2015 19
Draft Accessories guidance

DEFINES “ACCESSORIES” NARROWLY --

• Accessory: A device that is intended to support, supplement, and/or 

augment the performance of one or more parent devices. 

• Parent Device: A finished device whose performance is supported, 

supplemented, and/or augmented by one or more accessories. 

PROPOSES A POLICY THAT 

• Classification of accessories will be similar to the risk-based 

classification that FDA applies to all medical devices, and

– Risk of an accessory are the risks that it presents when used with 

the corresponding parent device as intended 

• Allows for a de novo submission requesting FDA to make a 

classification determination for new accessory types.

02/24/2015 20
In Summary

FDA’s Policies Drive 

Towards... Digital Health

• Promoting patient 

engagement technologies

• Providing regulatory clarity 

by using focused regulatory 

oversight

• Understanding and 

addressing stakeholder needs 

and expectations

• Beneficial to drive better 

health outcomes

• Enables patients 

empowerment 

• Enables efficient health care 

– processes and decisions

02/24/2015 21
Questions on Draft Guidance?

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar 

Recording will be available at:

www.fda.gov/CDRHWebinar under the “Past 

Webinars and Stakeholder Calls-2015” tab.

02/24/2015 22