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FDA & MOBILE/IT Applications

FDA & MOBILE/IT Applications. Drew Bennett Sr. Technical Licensing Specialist Office of Technology Transfer. The challenge…. The challenge…. Software is…. “ soft ” “ partly invisible ” “ subject to change ”. Facts/Clarity vs . Folklore. Actual things that I have heard people say….

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FDA & MOBILE/IT Applications

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  1. FDA & MOBILE/IT Applications Drew Bennett Sr. Technical Licensing Specialist Office of Technology Transfer

  2. The challenge….

  3. The challenge…. Software is… • “soft” • “partly invisible” • “subject to change”

  4. Facts/Clarity vs. Folklore

  5. Actual things that I have heard people say…

  6. Folklore • My APP does not need FDA clearance, its free… • I already got it on the APP store so it is legitimate… • We are a non-profit so our APP is not subject to FDA regulation… • My APP is not connected to any other systems so it is ‘OK’… • The FDA does not have clear guidelines so I am fine… • The FDA Guidelines are nonbinding…

  7. Fact: The FDA does have guidance

  8. FDA Draft Guidance – July 21, 2011 NEWS FLASH Update 9-25-2013

  9. FDA Updated Guidance – September 25, 2013

  10. Clarity….sort of

  11. That is great, because I was having trouble sleeping..

  12. Key Guidance Points • Discretionary Enforcement • Specific Examples Outlined: Appendix A, B & C • Medical Device APPS (Appendix C)– Sensors, Attachments, Measurements, Treatment Functions • Transitional APPS (Appendix B) – Prompts, Symptom Tracking, Usage Tracking, Checklists, Notifications, Reminders • Non-Medical Device APPS (Appendix C) – Education, Training, Coaching, Wellness, Office Automation/Health Care Setting Update: http://1.usa.gov/nKd3bA

  13. I still need help, that was about as clear as…

  14. U-M TTO Regulatory Guidance Template for Initial Regulatory Assessment of Software Applications • Who is the user? (e.g., Physician, nurse,  patient) • What is the purpose of the app? (Provide a 1 paragraph description) • Is it intended for a specific disease or condition? If so, what? • It is intended to be used to screen for or diagnose a disease or condition? If so, describe. • What are the inputs to the app? Be specific. • What are the outputs of the app? Be specific. • If the app provides recommendation for patient treatment, briefly describe the scientific basis for the algorithm used to generate the treatment recommendations. • What is the hardware platform? • How will the software be provided? (e.g. downloaded from App store, pre-installed on hardware platform).

  15. What is the FDA looking for? • Risk - Uncertainty • Process Control – SDLC/QSR • Requirements • Design & Development • Code Management • Testing & Verification • Validation & Traceability • Documentation • Security • Coaching - Decision Support

  16. “New” News

  17. THANK YOU!

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