This medical device webinar will discuss the FDA guidance on Mobile Medical Applications and provide clarification on the primary points of the guidance.
This webinar will discuss what apps are regulated by FDA under its device authority, the grey areas, the risks involved for device manufacturers and key issues that need to be addressed.
Why Should You Attend:
In July 2011, FDA published a draft guidance entitled 'Mobile Medical Applications”. This guidance was issued on September 25, 2013 and, though not binding, it reflects FDA’s current thinking on use of mobile applications as medical devices.This webinar will discuss what apps are regulated by FDA under its device authority, the grey areas, the risks involved for device manufacturers and key issues that need to be addressed.
Areas Covered in the Webinar:
- Background of the guidance
- Define mobile platforms, mobile app, mobile medical app
- When is a mobile app also a medical device?
- Examples of mobile apps that are not medical devices
- Examples of mobile apps that are medical devices
- Regulatory approach
- Regulatory requirements
Who Will Benefit:
This webinar will provide valuable assistance to following personnel in the medical device industry:- Regulatory affairs
- Project managers
- Staff involved with regulatory filings
- Product Development managers
- Mobile and Smartphone Companies
- Scientists
- Research Analysts
Course Provider
Cheryl Wagoner,
