Monday, July 15, 2013

FDA Draft Guidance - Mobile Medical Apps - Practical Insights

A quick and insightful perspective on the much anticipated mobile medical app guidance . . .

Compliance Zen: Majority of Mobile Health Apps Class II Devices for FDA:

"FDA’s current draft guidance on mobile medical apps is woefully short of such practical specifics. And yet it’s these specifics that will get even the most forthright medical app developer in trouble with FDA-483s and Warning Letters. Warning Letters have been shown to reduce product sales by at least 8% the first year and for three years thereafter. For many of these developers, a Warning Letter might be the kiss of death and bring a painful chill to the innovation marketplace."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
GMP Posters by SkillsPlus Intl Inc.
SkillsPlus Intl Info Blog

The Exemptee Institute
The Designated Representative Institute

The Health, Drug, Prescription, and GMP Supersite Gift Store 

TrackBack URL for the article cited above:

No comments:

From SkillsPlus International Inc.

Custom Search

Even More Resources, Books, & Things (many from

    GMP Training Gifts & Giveaways