Articles on Mobile Health Applications and FDA Regulation

Check these out…

Dear FDA: Qualcomm’s Robert Jarrin lists his wishes for FDA regulatory action

Where is the ‘fine line’ between safety and free rein for mobile development?

Some thoughts…

  • At risk of ending up on some government list of subversives, I question how often FDA (or equivalent agency in other countries) regulations actually result in protecting patients when they are applied to health IT products. Yes, good design, development, and validation practices are necessary for quality products. And, yes, health IT products are managing very important, not to mention legally protected, information that—when misused or when a defect affects its operation—can result in improper actions being taken …sometimes with adverse effects. But, for those that have worked for a registered medical device manufacturer, we spend more time with our eyes on paperwork than we should be. Time we could be spending on better design, or additional testing before launch. Too much of the paperwork is about evidence creation, and not about actual quality. Many process and method innovations developed in general IT product development are often difficult to adapt to the expected models in the FDA’s so called good manufacturing practices (GMP), and therefore do not achieve the same benefits/results.
  • If the U.S. government is generating revenue from the new medical device excise tax, is it possible that the FDA may be motivated to determine that more, not fewer, mobile apps are medical devices, and therefore subject to taxation? OK, I may have crossed the line into full-fledged conspiracy theory there. Sorry about that.


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