Digital HealthFDA as a partner in advancing health care

for patients

Digitization Across the Health Care Continuum

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Leveraging computing power, sensors, connectivity and software

Moving healthcare from the

Clinic to the Patient

Understanding patient’s

behavior and physiology “In

the wild”

Focusing on prevention for

early/smaller interventions

Smart Regulation Principles

Risk Based

Functionality Focused

Platform Independent

Promote Innovation

Narrowly Tailored

Promote Patient Engagement

Protect Patient Safety

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Focusing on Higher Risk Functionality

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Higher risk functionality

Appropriately oversee to assure patient safety while considering advances in technology and product life-cycle

• Engaging stakeholders• Implementing policies• Raising staff expertise and knowledge

Lower risk functionality

Don’t intend to enforce regulatory requirements

What did you

design it do?

• What is it for?

• Who is it for?

• When is it used?

“Intended for use” – A two part question

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What do you

say about it?

• What is it for?

• Who is it for?

• When is it used?

“Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or

prevention of disease, in man or other animals”

What did you

design it do?

• What is it for?

• Who is it for?

• When is it used?

“Intended for use” – A two part question

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What do you

say about it?

• What is it for?

• Who is it for?

• When is it used?

“Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or

prevention of disease, in man or other animals”

“Intended Use”

Digital Health Foundational Policies

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Approach to Mobile Apps

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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” definitionbut 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

Examples of Mobile Apps which are 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.

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Mobile Medical Apps (MMA)

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“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

MMAfocus of

oversight

Wearable Technologies

Fitness Wearable Example – Not Regulated

• Activity Sensors

• Measures HR and activity• Intended to maintain/encourage a healthy lifestyle• HR is used to assess level of exertion

ExampleK152954 - Quell

• Quell is intended for use as a transcutaneous electrical nerve stimulation (TENS) device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities.

• Quell is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.

General Wellness Devices• Final Guidance Published July 29, 2016

– Defines General Wellness Products as those which meet the following two factors:• Intended for only general wellness use• Present a very low risk to users safety

– https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429674.pdf

• 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

The products FDA regulates…

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A risk based approach for medical devicessince 1976

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Class I•General Controls

Class II•General controls•Special controls

Class III•General controls•Premarket approval (PMA)

Increasing RiskClassification determines extent of regulatory control (Risk Based)

General Controls•Electronic Establishment Registration •Electronic Device Listing•Quality Systems •Labeling•Medical Device Reporting (MDR)•Premarket Notification [510(k)] (unless exempt)

Special Controls (addressing Risk)•Guidelines (e.g., Glove Manual)•Mandatory Performance Standard•Recommendations or Other Actions•Special Labeling (e.g., 882.5970, Cranial Orthosis)

Regulatory Tools

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•What is the device

•Who is the Manufacturer

Registration and ListingPremarket Notification 510(k),

or

Premarket Approval (PMA),

•Confidential independent review prior to

commercial distribution

•Provide cross product lessons learned

Investigational Device Exemption (IDE)

for clinical studies

•Allowing new technology creation

Quality System (QS) regulation

•Non prescriptive principles for good

engineering and manufacturing

•Scalable for technology

Labeling requirements

•Establishes clear user

expectations

Medical Device Reporting

(MDR)

•Understand device issues and

impact on patients

Compliance program

•Correct defective product consistently

•Periodic monitoring to assure device quality is sustained

Quality Management PrinciplesA grouping of QMS activities from a Software perspective

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-151002-samd-qms.docx

Resources• 513(g)• Pre-submission• Digital Health and Mobile Apps email

– DigitalHealth@fda.hhs.gov– MobileMedicalApps@fda.hhs.gov

• CDRH websites– Digital health page

• http://www.fda.gov/MedicalDevices/DigitalHealth/default.htm

– 510(k) database with Summaries

Reimagining a new paradigmFostering Medical Innovation: A Plan for Digital Health DevicesFDA commissioners Blog – 6/15/2017

By: Scott Gottlieb, M.D.

…….. In addition to these efforts, we are also announcing today a new initiative that FDA is undertaking. This fall, as part of a comprehensive approach to the regulation of digital health tools and in collaboration with our customers, FDA will pilot an entirely new approach toward regulating this technology. This will be the cornerstone to a more efficient, risk-based regulatory framework for overseeing these medical technologies. ……

https://blogs.fda.gov/fdavoice/index.php/2017/06/fostering-medical-innovation-a-plan-for-digital-health-devices/

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In summary

• FDA excited to participate in promoting evidenced based safe

innovation for a better healthcare system

• FDA is interested in advancing patient safety and protecting patient

information is the cornerstone of a better healthcare system

W O R K TO G E T H E R

R E A C H A L L PAT I E N T S

B E T T E R T R E AT M E N T S A N D O U TC O M E S

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