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

2. The challenge….

3. 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 FDA Draft Guidance – July 21, 2011 NEWS FLASH Update 9-25-2013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 1.Who is the user? (e.g., Physician, nurse, patient) 2.What is the purpose of the app? (Provide a 1 paragraph description) 3.Is it intended for a specific disease or condition? If so, what? 4.It is intended to be used to screen for or diagnose a disease or condition? If so, describe. 5.What are the inputs to the app? Be specific. 6.What are the outputs of the app? Be specific. 7.If the app provides recommendation for patient treatment, briefly describe the scientific basis for the algorithm used to generate the treatment recommendations. 8.What is the hardware platform? 9.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!