Should Mobile Medical Apps Require FDA Approval?

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Updated June 10, 2021

The links in the original post broke.

You can read more about this topic here:

Device Software Functions Including Mobile Medical Applications - FDA.gov

---  the original post follows below  ---

Should Mobile Medical Apps Require FDA Approval? - Healthcare - Mobile and Wireless - Informationweek:  

Mobile Medical Apps Meet The FDA, Part 2 - Healthcare - Mobile and Wireless - Informationweek: 

A nice pair of articles, fairly and delicately balancing how much is enough, versus too much FDA regulation.

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OK Folks, Get Walking! Huge Health Benefits

Kaiser Permanente leader touts the myriad benefits of walking.



So what are you waiting for?!

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FDA approves Cialis to treat benign prostatic hyperplasia

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Updated April 16, 2017:

The original link broke. You might also be interested in:
Tadalafil (Cialis) - (on MedlinePlus), and

FDA Approves Cialis to Treat Enlarged Prostate - WebMD

- -  original post follows below  - -

Image via WikipediaPress Announcements; FDA approves Cialis to treat benign prostatic hyperplasia:   'via Blog this'

'nuff said.

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Surviving FDA Enforcement Actions - Free Tips

Life in FDA’s fast lane | News | Packaging World:  'via Blog this'

In the article, LeeAnn Rogus offers many tips. Here's just one of the many pearls of wisdom that's shared:

"The 15 days FDA gives a company to respond to a Form 483 inspectional observation has always existed, but the agency would usually let you have extra time. Not any more."

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FDA Notes Primatene Mist Departure

Medical News: FDA Notes Primatene Mist Market Departure - in Product Alert, OTC from MedPage Today:     'via Blog this'

The only over-the-counter asthma inhaler sold in the United States will no longer be available next year as part of a phase-out of epinephrine inhalers containing chlorofluorocarbons (CFCs).

Epinephrine CFC inhalers, marketed as Primatene Mist, are being phased out because they use CFCs as a propellant (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs. 

Primatene Mist is approved by the Food and Drug Administration (FDA) for the temporary relief of occasional symptoms of mild asthma.

If you're a Primatene Mist user, the FDA recommends that you see a health care professional soon to get another medicine. A doctor, physician assistant, or nurse practitioner can all help you determine the best treatment option for you. Primatene Mist may be harder to find on store shelves even before Dec. 31, 2011.

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