Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Health Data Management, in “FDA Seeks Input on Clinical Evaluation of Software as a Medical Device,” by Greg Slabodkin.

Following is an excerpt:

While this is a document developed by the IMDRF, when finalized the guidance will represent FDA's current thinking on the topic of the clinical evaluation of standalone software. As such, Bradley Merrill Thompson, an attorney at Washington-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, believes this guidance is a big deal.

“Digital health is an exploding field, so this may affect quite a few products down the road,” says Thompson. “There are a huge number of mobile apps as well as stand-alone programs for PCs that are finding their way into the practice of medicine, and this guidance lays out the requirements for clinical evaluation.”

Typically, clinical evaluation is one of the most expensive aspects of product development, “so the requirements of this guidance have a major impact on both the cost and the time frames for bringing products in these categories to market,” he says.

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.