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

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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…. - PowerPoint PPT Presentation

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Page 1: FDA & MOBILE/IT Applications

FDA & MOBILE/IT ApplicationsDrew BennettSr. Technical Licensing Specialist Office of Technology Transfer

Page 2: FDA & MOBILE/IT Applications

The challenge….

Page 3: FDA & MOBILE/IT Applications

The challenge….

Software is…

• “soft”

• “partly invisible”

• “subject to change”

Page 4: FDA & MOBILE/IT Applications

Facts/Clarity vs. Folklore

Page 5: FDA & MOBILE/IT Applications

Actual things that I have heard people say…

Page 6: FDA & MOBILE/IT Applications

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…

Page 7: FDA & MOBILE/IT Applications

Fact: The FDA does have guidance

Page 8: FDA & MOBILE/IT Applications

FDA Draft Guidance – July 21, 2011

NEWS FLASH

Update 9-25-2013

Page 9: FDA & MOBILE/IT Applications

FDA Updated Guidance – September 25, 2013

Page 10: FDA & MOBILE/IT Applications

Clarity….sort of

Page 11: FDA & MOBILE/IT Applications

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

Page 12: FDA & MOBILE/IT Applications

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

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

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U-M TTO Regulatory GuidanceTemplate for Initial Regulatory Assessment of Software Applications1.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).

Page 15: FDA & MOBILE/IT Applications

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

Page 16: FDA & MOBILE/IT Applications

“New” News

Page 17: FDA & MOBILE/IT Applications

THANK YOU!