FDA & MOBILE/IT ApplicationsDrew BennettSr. 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…

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…

Fact: The FDA does have guidance

FDA Draft Guidance – July 21, 2011

NEWS FLASH

Update 9-25-2013

FDA Updated Guidance – September 25, 2013

Clarity….sort of

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

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

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

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).

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

“New” News

THANK YOU!