FDA (Food and Drug Association) and QS

Hi all,

A few weeks ago the FDA opened up a discussion about the regulation of mobile medical apps. How might these regulations impact QS startups? While the regulation of traditional medical devices is well established, I feel that a lot of the excitement around Quantified Self is using mobile apps to quickly experiment, analyze, and try new things. While regulation might filter out potentially harmful apps, I think would surely temper this excitement.

What do you all think of this? What might the discussions be like within zeo, fitbit, bodybugg, Tonic, 23andme, and other consumer health + tech companies? What discussions have you had within the community?

A few links for you to check out
MobiHealth news: http://mobihealthnews.com/11980/types-of-medical-apps-the-fda-will-regulate/

FDA site:


Great question, Tito! Health tech is such an interesting and dynamic area, as it deals with quite different groups: consumers and regulatory agencies like the FDA.

I’m afraid I don’t personally have insight into what the regulations mean for startups or large companies, but I would love to hear from those who’ve been in the field for a while. (Seasoned pros, please comment!)

There is an upcoming meeting (and webcast) focusing on the recent FDA guidelines. Should be worth a listen:

Subject: Wireless Health Group Announcement – FDA Public Workshop on Mobile Medical Applications Draft Guidance

The United States Food and Drug Administration (FDA) is holding a Public Workshop for their Mobile Medical Applications Draft Guidance on Sep 12-13 in Silver Spring, MD, USA (The meeting will be webcasted.)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:

I should also point out Paul Sonnier’s LinkedIn group, “Wireless Health,” a nearly 7k member strong group focused on the topic. I’m a member and recommend it based on the quality and relevance of news. http://www.linkedin.com/groups/Wireless-Health-2181454?home=&gid=2181454&trk=anet_ug_hm

Thanks for the post, Eri. The Wireless Health linkedin group has some pretty active conversations around this topic, thanks!


For those interested in the FDA regulation and living in Southern California you may want to attend the Town Hall Meeting on 9/14 sponsored by the Wireless-Life Sciences Alliance.

Details here.

Excellent, I’m gonna post to the Wireless Health group and see if there’s a town hall planned for SF. I’ll let you all know!