Android™ Medical Applications- Is it the future? » fda http://www.androidmedapps.com The blog to discuss future Android™ medical applications Wed, 02 Dec 2009 01:05:28 +0000 http://wordpress.org/?v=2.8.1 en hourly 1 How to get FDA to clear a mobile health app http://www.androidmedapps.com/index.php/2009/12/how-to-get-fda-to-clear-a-mobile-health-app/ http://www.androidmedapps.com/index.php/2009/12/how-to-get-fda-to-clear-a-mobile-health-app/#comments Wed, 02 Dec 2009 01:01:43 +0000 piy http://www.androidmedapps.com/?p=203 Since past few months, mobile health application developers have been looking for answer to their two questions: 1) When is FDA clearance required? 2) How to achieve FDA clearance?

Bradley Merrill Thompson has answered the above two questions in his article at mobilehealthnews . The article in 3rd in series where in first article, he outlined what factors FDA considers while deciding which products need to be regulated. In second article, he outlined basic steps for getting medical device cleared by FDA.

The article is must read for any mobile health application developers considering selling their applications in US.

]]> http://www.androidmedapps.com/index.php/2009/12/how-to-get-fda-to-clear-a-mobile-health-app/feed/ 0 FDA may regulate certain mobile phones, accessories http://www.androidmedapps.com/index.php/2009/07/fda-may-regulate-certain-mobile-phones-accessories/ http://www.androidmedapps.com/index.php/2009/07/fda-may-regulate-certain-mobile-phones-accessories/#comments Mon, 13 Jul 2009 23:34:21 +0000 piy http://www.androidmedapps.com/?p=186 According to Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C., that FDA might regulate certain equipment like cell phones that companies are planning to put at the center of connected health services.

In his article, he outlines the factors that FDA considers when deciding whether to regulate such equipment.

The Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:

“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either]
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or]
intended to affect the structure or any function of the body of man or other animals.”

For more details, visit mobihealthnews

]]> http://www.androidmedapps.com/index.php/2009/07/fda-may-regulate-certain-mobile-phones-accessories/feed/ 0