2011 05 03 understanding fda regulation of mobile health


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2011 05 03 understanding fda regulation of mobile health

  1. 1. Understanding FDA Regulation of Mobile Health May 3, 2011
  2. 2. Introductions Jafar Shenasa Senior Manager, Regulatory Affairs Aaron Filner Associate Director Health Application Platform2
  3. 3. AgendaState of regulatory and mHealthRegulatory questions for mHealth innovatorsBreakoutsReview and conclusions3
  4. 4. State of regulatory and mHealth4
  5. 5. 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 regulation5
  6. 6. 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 Market6
  7. 7. mHealth solutions can be more than an app on a phone -  Aggregate information Regulatory Implications -  Drive a simple behavioral change -  Deliver that information to medical professionals -  Inform medical decisions by patients, and/or by doctors7
  8. 8. Where and when is mHealth regulated by the FDA? Components of an mHealth solution are regulated if they are “medical devices” But what does that mean?8
  9. 9. “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 purposes9 *Food, Drug, and Cosmetic Act § 201(h)
  10. 10. The anatomy of mobile health solutions10 * Source: http://mhealthregulatorycoalition.org/wp-content/uploads/2010/12/mrcwhitefinal122210.pdf
  11. 11. The anatomy of mobile health applications11 * Source: http://mhealthregulatorycoalition.org/wp-content/uploads/2010/12/mrcwhitefinal122210.pdf
  12. 12. Classes of medical devices 3 Classes, ~ 1700 different generic types Unregulated Class I Class II Class III Unregulated Class I Fitness monitor Medical claim Not a medical device Subject to general controls Adulteration, Misbranding Easy access to market No pre-market auth required No medical claims Generally inexpensive No reimbursement Reimbursed as part of12 procedure
  13. 13. Classes of medical devices 3 Classes, ~ 1700 different generic types Unregulated Class I Class II Class III Class II Class III “Me Too” regulated products Critical regulated products Requires general & special Highest level of scrutiny controls Safety/ Effectiveness must be demonstrated Generally requires pre-market Subject to pre-market notification (510(k)) approval Significant cost Tremendous cost13 Reimbursement likely Reimbursed to be viable
  14. 14. 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 phone14
  15. 15. “Medical Device Data System” (MDDS) defined -  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, 201115
  16. 16. How is the software in a mHealth solution regulated? 1. Medical claim? The FDA focuses on -  Risk associated with 2. Software’s function(s) the use of software -  Display and Storage -  Transmission -  Intended use of the -  Collection connected device -  Analysis or conversion16
  17. 17. It’s all about intended use No FDA Oversight High FDA Oversight Medical Manage Weight High weight chronic scale sensitivity scale conditions •  Shows weight •  Add memory •  Delayed •  Live physician •  Export weight physician updates via cable/BT reporting •  Track your •  Weight own weight •  Record your •  Weight monitoring own weight monitoring critical in over time aids in long detecting heart term obesity failure care Align claims with marketing and intended use17
  18. 18. 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 quality18
  19. 19. Data, privacy, and the FDA What about HIPAA?19
  20. 20. Regulation beyond the FDA -  European bodies -  International regulatory considerations -  Device approval often secured 2-3 years sooner in Europe -  No significant difference in product safety20
  21. 21. Regulatory questions for mHealth innovators21
  22. 22. 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?22
  23. 23. 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?23 !
  24. 24. 3. Collecting and Managing Data •  How does the use of data affect regulation •  When is HIPAA compliance a factor? Not a factor?24
  25. 25. 4. Humans •  How does a human’s role in your solution impact regulatory considerations?25
  26. 26. 5. Balancing Rapid Iteration and Regulatory Needs •  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?26
  27. 27. Breakouts27
  28. 28. 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?28
  29. 29. Review and conclusions29
  30. 30. Thank You Jafar Shenasa Aaron Filner30