Commentary: FDA’s Website Has Wrong Information About the Scope of Its Software Regulation — And That’s a Big Problem

MobiHealthNews

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.