FDA Guidance on Mobile Medical Apps

Duration: 60 Minutes
The FDA's recent guidance on mobile medical apps addresses different regulatory requirements for categories of apps and coupled equipment. This course will provide a practical overview of mobile medical app regulations including examples of devices and companies that have gone through the process. Review differences between mobile medical apps regulated by FDA discretion/ un-regulated. Explore regulatory filing strategies with case studies and innovative approaches to mobile health products. The FDA supports the progress of mobile medical apps that betters healthcare and supplies consumers and healthcare professionals with precious health information. The FDA also has a public health responsibility to manage the safety and efficacy of medical devices - including mobile medical apps.
FDA regulations
Instructor: David Amor
Product ID: 500459

The FDA has issued the Mobile Medical Applications Guidance for Industry as well as Food and Drug Administration Staff on September 25, 2013. This guidance describes the agency's oversight of mobile medical apps as devices and concentrates only on the apps that poses a larger risk to patients if they don't work as planned and on apps that cause androids or iOS to impact the functionality or of traditional medical devices.

Why Should you Attend:
Mobile health is the new frontier for medical devices and represents a whole new regulatory framework for companies. Mobile apps uses GPS data to alert asthmatics regarding environmental conditions that could trigger asthma symptoms or alert an addiction patient when he/she is near a high-risk location. Mobile apps uses games and videos to motivate patients to do their physical therapy exercises at home.

Objectives of the Presentation:
  • Mobile medical app regulations.
  • Filing strategies and examples
Who can Benefit:
  • Medical device professionals - particularly in digital health
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
David Amor is a medical device consultant, having worked with companies such as Boston Scientific, St. Jude Medical and Hospira in helping develop quality management systems and product development infrastructures. A graduate of the Senior Innovation Fellows program at the University of Minnesota Medical Device Center, David was named a Top 40 Under 40 Medical Device Innovator in 2012 and founded MEDgineering, a niche quality consulting firm focusing on FDA remediation and remote work solutions (www.medgineering.com). David has a strong technical background, having garnered his BS and MS in Biomedical Engineering from the University of Miami with a focus on innovating around clinical needs. He is a published speaker, participating in most major medical device trade shows, including presentations at MD&M East and MD&M West, the two largest medical device conferences in the world, where he lectures on topics centering on innovative compliance practices. He also currently serves as Chief Operating Officer of ReMind Technologies, a mobile health start-up dedicated to tackling medication adherence by using smart-device based medication dispensing units and software applications.
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