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Medical Apps, Disruptive Innovation, and Regulatory Timing
Transcript of Medical Apps, Disruptive Innovation, and Regulatory Timing
and Regulatory Fortitude Nathan Cortez firstname.lastname@example.org iStethoscope First generation Agenda 1. Mobile health revolution
2. FDA's approach?
3. Agency threats?
4. Regulating with backbone Airstrip Patient Monitoring Airstrip OB Mobile MIM iBGStar Reka E100 Not regulated by FDA? Textbooks, teaching aids, references Record, track health & wellness Office automation Diagnostic tools? All-in-one assistants? FDA's approach Agency threats? Threats: > Guidance documents
> Warning letters
> Press releases When? > High uncertainty
> Rapidly changing industries, technologies
> Agencies lack sufficient info to "make law" Why? > Avoids stifling new technologies
> Fosters open public debate
> Quicker, more flexible Empty threats? 1987 1989 2000 2011 2005 Draft Policy for the Regulation of Computer Products Draft Policy for the Regulation of
Computer Products FDA to consider risk-based classifications? FDA withdraws 1989 Policy A final reg! (21 CFR 880.6310)
But covers least-risky category The Wonders and Brutality of Medical Devices