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The FDA recently released a draft guidance for mobile medical applications and called for public comments. The guidance focuses oversight on those apps that the FDA sees as having the greatest potential risk to patients.
According to the FDA press release, the agency’s draft guidance defines a small subset of mobile medical apps that may impact the performance or functionality of medical devices that are currently regulated. This subset includes mobile medical apps that:
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Are used as an accessory to a medical device already regulated by the FDA.
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Transform a mobile communications device into a regulated medical device by using attachments, sensors, or other devices.
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This draft guidance will now give the pharma industry parameters within which to work.
The guidance was a lively discussion topic on one of our recent #SocPharm Tweetchats. See what some of the foremost
industry thinkers had to say about its impact on mobile health applications.
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Siren in the Media
A blog post written by Wendy White, Founder and President of Siren Interactive, was featured on PharmaPhorum, a global hub for constructive industry debate, thought leadership and sharing of ideas. The post is the first in a six-part series titled, Rare Is Different
, and in it, Wendy tells her personal story as the parent of a child with a rare disorder and illustrates how empowered patients and caregivers are changing marketing for rare disorder therapies. Be sure to stay tuned for the rest of the series with a new post appearing each month.
Wendy was also featured in the recent Washington Post supplement on rare diseases along with industry leaders like Peter Saltonstall, President and CEO of the National Association for Rare Disorders (NORD); Jamie Manganello Ring, Senior Director of Genzyme Patient Advocacy; and Nicole Boice, CEO of the Children’s Rare Disease Network.
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