Wednesday, June 1, 2011

Medical apps have FDA regulation on the way

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Medical apps are slated to get FDA guidance later this year through the Center for Devices and Radiological Health. The majority of apps being used by the medical world today are information based and are therefore not required to be FDA approved, but next generation apps will be instrumental in the diagnosis and treatment of patients, making it more important to regulate them.

According to American Medical News, the FDA has recently indicated that it will begin to regulate these, and could provide a guidance later this year. The Center for Devices and Radiological Health will be the ones regulating and issuing guidance for these apps. Some companies have gone ahead and applied for approval on an ad hoc basis, but it is likely that this will get tougher to do in the coming year.

ePharma Summit West has multiple sessions both on mobile apps and regulatory compliance, including “Paging Doctor PC: Your Search Results are In,” “The Art of Mobile Workshop,” The Digital Tools Focus Track, and “What Does Pharma Want from DDMAC” presented by Peter Pitts of Porter Novelli and the Center for Medicine in the Public Interest. Download the brochure to check out these sessions and more, plus register by this Friday to save $400. Take an extra 10% off when you mention the code XP1656BLOG.

Do you think we'll see guidance on clinical Apps before we see recommendations for the use of social media for the Pharmaceutical marketing?
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