I sent the following announcement to 6,700+ Wireless Health LinkedIn Group Members on August 12, 2011:
Wireless Health Group Announcement – FDA Public Workshop on Mobile Medical Applications Draft Guidance
The United States Food and Drug Administration (FDA) is holding a Public Workshop for their Mobile Medical Applications Draft Guidance on Sep 12-13 in Silver Spring, MD, USA (The meeting will be webcasted.)
Complete details can be found here.
Background: On July 19, 2011, FDA announced it is seeking input on its oversight approach for certain mobile applications specific to medicine or health care called mobile medical applications (“apps”) that are designed for use on smartphones and other mobile computing devices. Through this draft guidance the FDA defined a small subset of mobile medical apps that may impact on the performance or functionality of currently regulated medical devices and as such, will require FDA oversight.
The purpose of the workshop is to provide a forum for discussion with FDA and to encourage public comment from interested stakeholders on the following topics:
- Aspects of draft guidance document entitled “Mobile Medical Applications”
- How the Agency should approach accessories and particularly mobile medical applications that are accessories to other medical devices; and
- Standalone software that provides clinical decision support.
The FDA encourages feedback from manufacturers, health care providers and others on how its proposal may support the balance between promoting innovation and assuring safety and effectiveness. Submit either electronic or written comments on the draft guidance by October 19, 2011.
I’ve posted this event to the Global Event List for Health Innovation that I maintain on my personal website: https://www.wirelesshealthstrategies.com or https://www.wirelesshealthstrategies.com/events.html
Also, I added it to the Global Health Innovation Event List Discussion in the Wireless Health group on LinkedIn: http://lnkd.in/ppGgcj (Please note that you can “follow” this discussion to receive an email notification whenever someone posts a new event as a comment in the discussion.)
Lastly, I also maintain a Google Calendar version of the Event List.
VP, Partner Development, Wireless-Life Sciences Alliance (WLSA)
Founder, Wireless Health group on LinkedIn
Twitter, Blog, Wireless Health Daily
Upcoming WLSA Events in San Diego, CA:
Wireless Health 2011 Academic Industry Conference (Oct 10-13, 2011)
7th Annual Convergence Summit (May 23-24, 2012)
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