Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in an article about the FDA actively watching app stores for apps that it deems fill a medical purpose, with an eye toward regulating them.

Thompson said even smartphone apps require FDA approval, just like other medical "devices," and the determination if an app requires federal approval is strictly the FDA's call.

According to Thompson, it isn't clear which apps might trigger FDA scrutiny.

In an article that Thompson wrote in 2009, he noted the FDA could even regulate cell phones used for medical purposes. He pointed out that once a program is committed to computer media, "media with the code written on it is enough of a 'thing' for FDA to regulate."

According to Thompson, the FDA is actively engaged in surveillance of various app stores to see if apps should trigger their involvement. Applications where a smartphone is connected in any way to imaging are under scrutiny, in particular. Any app that is used to transmit images to a medical facility requires FDA approval.

Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.