Understanding FDA Regulation of Mobile Health

May 3, 2011

Introductions

Jafar Shenasa Senior Manager, Regulatory Affairs

Aaron Filner Associate Director Health Application Platform

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Agenda

State of regulatory and mHealth Regulatory questions for mHealth innovators Breakouts Review and conclusions

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State of regulatory and mHealth

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Why is regulation interesting

-  We are in the early stages of mHealth regulation

-  Predictability in regulation is crucial

-  Opportunity to partner with the FDA to find the right combination of rapid innovation and safety regulation

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What is Mobile Health?

Acquiring and delivering health data outside of a clinical facility

! 15K medical, health, fitness apps in App Store ! 400% growth since 2009 ! Rapid growth in the Android Market

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mHealth solutions can be more than an app on a phone

-  Aggregate information

-  Drive a simple behavioral change

-  Deliver that information to medical professionals

-  Inform medical decisions by patients, and/or by doctors

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Regulatory Implications

Where and when is mHealth regulated by the FDA?

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Components of an mHealth solution are regulated if they are “medical devices” But what does that mean?

“Medical Device” defined

Any article, components part, or accessory which is “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”*

or

“Intended to affect the structure or any function of the body of man or other animals”* It does not depend on being metabolized for the achievement of any of its primary intended purposes 9 *Food, Drug, and Cosmetic Act § 201(h)

The anatomy of mobile health solutions

10 * Source: http://mhealthregulatorycoalition.org/wp-content/uploads/2010/12/mrcwhitefinal122210.pdf

The anatomy of mobile health applications

11 * Source: http://mhealthregulatorycoalition.org/wp-content/uploads/2010/12/mrcwhitefinal122210.pdf

Classes of medical devices 3 Classes, ~ 1700 different generic types

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Unregulated

Fitness monitor Not a medical device

Easy access to market No medical claims No reimbursement

Class I

Medical claim Subject to general controls Adulteration, Misbranding

No pre-market auth required Generally inexpensive Reimbursed as part of

procedure

Unregulated Class I Class II Class III

Classes of medical devices 3 Classes, ~ 1700 different generic types

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Class II

“Me Too” regulated products Requires general & special

controls

Generally requires pre-market notification (510(k))

Significant cost Reimbursement likely

Class III

Critical regulated products Highest level of scrutiny

Safety/ Effectiveness must be demonstrated

Subject to pre-market

approval Tremendous cost

Reimbursed to be viable

Unregulated Class I Class II Class III

The accessory rule

Components -  Part of a finished device -  Regulatory burden on finished device -  e.g. Firmware that controls a device

Accessories -  Is not part of the finished device -  Can be purchased directly from manufacturer -  Compatible with device -  Regulatory class determined by parent device if not separately classified -  e.g. mobile app, mobile phone

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“Medical Device Data System” (MDDS) defined

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-  Intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data.

-  Must not control or alter the function or parameters of any connected medical devices.

-  Not intended to be used in connection with active patient monitoring (diagnostic or clinical decision making).

MDDS are Class I devices as of April 18, 2011

How is the software in a mHealth solution regulated?

1. Medical claim? 2. Software’s function(s) -  Display and Storage -  Transmission -  Collection -  Analysis or conversion

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The FDA focuses on -  Risk associated with

the use of software -  Intended use of the

connected device

It’s all about intended use

Weight scale

•  Shows weight

•  Track your own weight

Medical weight scale

•  Add memory •  Export weight

via cable/BT

•  Record your own weight over time

Manage chronic

conditions

•  Delayed physician reporting

• Weight monitoring aids in long term obesity care

High sensitivity

•  Live physician updates

• Weight monitoring critical in detecting heart failure

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Align claims with marketing and intended use

No FDA Oversight High FDA Oversight

Best practices for software

Medical device: Design controls are required -  Verification & Validation -  Documentation

Non-medical devices: Industry best practices -  Creator continues to hold responsibility

for quality

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Data, privacy, and the FDA

What about HIPAA?

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Regulation beyond the FDA

-  European bodies

-  International regulatory considerations

-  Device approval often secured 2-3 years sooner in Europe

-  No significant difference in product safety

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Regulatory questions for mHealth innovators

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1. Conduit Classification

•  When should a conduit be treated as an MDDS and Class I device?

•  Is a cell phone regulated?

•  How do Wi-Fi, Cellular, the internet, and other communication mediums factor into conduit classification?

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2. Regulating Elements of A Solution

•  What elements of your solution require what levels of regulation?

•  What elements are subject to the accessory rule in what circumstances?

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3. Collecting and Managing Data

•  How does the use of data affect regulation

•  When is HIPAA compliance a factor? Not a factor?

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4. Humans

•  How does a human’s role in your solution impact regulatory considerations?

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5. Balancing Rapid Iteration and Regulatory Needs

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•  What are the criteria for prioritizing rapid iteration and reducing regulatory risk?

•  Can I change product strategy and claims to reach the market more quickly with a lower risk product?

•  How do priorities change for products that focus on a single development phase or ongoing development?

Breakouts

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Breakout selection

3 groups, 30 minutes 1.  Conduit Classification 2.  Regulating Elements of A Solution 3.  Collecting and Managing Data 4.  Humans 5.  Balancing Rapid Iteration and Regulatory Needs 6.  Write-ins?

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Review and conclusions

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Thank You

Jafar Shenasa Aaron Filner

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