Commentary: FDA’s website has wrong information about the scope of its software regulation — and that's a big problem

Ironically, the agency that goes after companies for false and misleading claims is making them about its own policies.
By Bradley Merrill Thompson
11:07 am

About the Author: Bradley Merrill Thompson is a member of the firm at Epstein Becker & Green, P.C. There, he counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. The opinions in this piece are Thompson's and don't necessarily reflect the opinions of MobiHealthNews or HIMSS.

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.

Background: Implementing statutory changes

Without trying to turn you into a law student, I need to explain the basic U.S. legal framework. Our system of law is hierarchical, with different levels of authority.  And each level must conform to the authority above it.  It’s important to understand this because it means that when Congress changes a statute, the agencies are then responsible for changing their regulations and guidance to conform to the new statute. So here are the four basic levels:

  1. Constitution. In the United States, the power ultimately belongs to the people.  The Constitution is the supreme law of the land, and the ability to change the Constitution resides with the people.  All other laws must conform to the Constitution.
  2. Statutes. Congress has the power to legislate statutes. But statutes must conform to the Constitution.
  3. Regulations. Federal agencies have the power to promulgate regulations, but the regulations must conform to the congressionally-enacted statutes.
  4. Agency Guidance. Federal agencies have the power to explain and interpret their regulations, and they do so in the form of guidance. But guidance must conform to the agency’s regulations and congressional statutes. Guidance documents actually have no legal power in and of themselves, but they do play a very important role by offering insight into how the agency interprets its authorities.

Impact of statutory changes

As already noted, when a statute changes, all of the legal authorities below that statute in the hierarchy need to be revised to conform to the statutory change. Obviously the more fundamental and broader the statutory change, the more changes likely need to be made to the regulatory and guidance levels.

Unfortunately, this is not some simple task. It requires judgment to identify erroneous statements and correct them. Typically this isn’t a matter of deleting entire documents, because documents often contain complex interwoven requirements that include some requirements unaffected by the changes above. Instead, updating regulations and guidance documents to properly reflect statutory changes requires careful legal analysis.


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