Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, authored an article in MobiHealthNews, titled “Commentary: FDA’s Website Has Wrong Information About the Scope of Its Software Regulation — And That’s a Big Problem.”

Following is an excerpt:

As a pro bono project, together with several friends in medical device regulatory affairs, I am traveling to eight major universities around the country this spring talking with entrepreneurs about the FDA regulatory issues associated with bringing artificial intelligence into healthcare applications. Our goal is to help startups figure out the regulatory path ahead of them, to open the door to more innovation that can hopefully save lives.

Through these discussions, we are learning that many startups are confused about the scope of what FDA regulates in the software space. Prior to our arrival, these entrepreneurs use FDA’s website to try to understand the agency’s requirements. But unfortunately, FDA’s website is full of false and misleading information that has led many of them to incorrect conclusions about whether their products are regulated.

With only a little effort, I found at least 10 FDA documents on its website that include wrong information. Some are incorrect because they fail to reflect the changes in the law from the 21st Century Cures Act enacted in 2016, while others are misleading because they state that FDA regulates something which, in fact, FDA does not as a result of so-called “enforcement discretion.”

If the agency truly wants to help spur innovation, my modest proposal is that FDA start by correcting the information on its website.

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.