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
Some false or misleading guidances on FDA's website.

Why outdated information on FDA’s website is a problem

I suspect most of you don’t need to read this section; it is intuitively obvious why erroneous information on FDA’s website is a problem. But I’m going to address it anyway.

If someone like an entrepreneur, or even an experienced attorney or regulatory consultant, finds those regulations or guidance documents through a Google search or otherwise, they have no reasonable warning that the regulation is incorrect. 

Further, with the existing guidance documents, their only clue that something is wrong is a terse warning on a cover sheet that something in the guidance document is not right. It’s up to the reader to then read the statute or find the new guidance document and figure out what’s wrong with the old guidance documents.

I can’t understand how anyone at FDA thinks that’s good government. Instead of directly fixing the half dozen or so outdated existing guidance documents, they left those guidances on the website and instead published a new one that describes the range of problems with those existing documents. To my way of thinking, it is better to revise incorrect laws, than to layer on additional laws to counteract them. FDA should not have come out with a new guidance to explain how to interpret the existing guidances. The agency should’ve simply directly proposed amendments to the outdated regulations and guidances.

The impact on innovation is quite serious. If FDA took the relatively simple step of updating its regulations and guidance, entrepreneurs at startup companies could help themselves by reading the documents directly, rather than hoping that some lawyer is willing to help them pro bono. Incorrect information means that the entrepreneurs may decide not to pursue worthwhile innovations because they erroneously conclude that the law would impose burdensome FDA regulation on the project, or the startups may proceed to implement a quality system and pursue expensive clinical trials specifically designed for FDA clearance, when FDA does not, in fact, regulate the product. 

Frankly even if an entrepreneur consults an attorney like me before heading down the wrong path, it’s ridiculous that they should have to pay money just to help them understand that the agency’s website is out-of-date in several fundamental ways. This is why, with a group of friends, I am teaching these university seminars — and publishing this article — in an effort to educate more entrepreneurs.

The root cause of the problem

So (1) if there’s a problem, and (2) if that problem is hurting a lot of people, and (3) if FDA knows about the problem and its negative impact, why isn’t the agency solving it? It’s important in a case like this to dig a little deeper to figure out exactly why this is happening. Surely no one thinks that leaving incorrect documents on the website for several years is the best approach. There must be a reason why the agency is doing this.

For context, it’s important to understand that FDA does not like this particular section of the 21st Century Cures Act.  For transparency, I represented the Clinical Decision Support (or CDS) Coalition, a group of companies and other organizations that wanted a clear and rational dividing line between regulated and unregulated CDS. For years we urged FDA to adopt as a dividing line the principle of transparency. As we explained it to FDA, transparency means that if a piece of software is transparent (i.e. not a black box), and more specifically if the healthcare professional user can see the data inputs and understand how the software is calculating its recommendations, the healthcare professional remains firmly in control of the decision-making and we argued the software should not be FDA-regulated.

FDA agreed that transparency reduces risk, but did not agree that it should a dividing line between regulated and unregulated CDS. So off to Congress we went. And Congress, through a bipartisan effort, agreed with us and added section 3060 to the 21st Century Cures Act. But FDA clearly did not like the idea of transparency as a basis for regulation and indeed they resisted the idea that any legislation was necessary for this topic.

Now, three years later, if you ask the agency why they are waiting so long to publish changes to their guidance and regulations, they will likely tell you it’s a question of money and manpower. I’m told that modifying regulations and guidance documents requires going through an extensive process that requires a myriad of signatures within the agency and at OMB. And FDA says we’d rather spend the money on other things. 

I’ve got several problems with that.

First, I believe there is money that could be redirected without impairing other programs. It simply is not that expensive to update the regulations and guidance compared to the overall FDA budget.

When an organization the size of FDA says that it doesn’t have the money for something this small, what it really means is that the requested action isn’t a priority for the agency. If the agency wanted to get it done, it would be done.  It’s apparently not bothering anyone at FDA that the congressional statute is not being implemented in a timely way.

Second, FDA’s failure to prioritize this need underestimates the negative impact on innovation of having a website that is so misleading to the engineers and clinicians who are trying to start new businesses.  As I’ve explained, with some friends I’m going to eight universities to talk to startups about when FDA compliance is required for software that uses artificial intelligence. It’s very sad to me to learn how many people are utterly confused by the information on FDA’s website.

Third, government agencies charged with regulating important areas of commerce and enforcing criminal laws have an obligation to correctly implement and clearly explain the laws they enforce, in a timely way.  It’s hard to think of anything more central to the mission of the agency.

This post is dripping with irony when I observe that the FDA has false and misleading information on its website. The words “false and misleading” come right out of the Federal Food, Drug and Cosmetic Act, and establish the standard that companies must meet for information they post on their websites. For the agency to permit its own website to include false and misleading information for years, at the same time bringing enforcement actions against companies they accuse of the same thing, is unacceptable.

Fourth, if the problem is that the guidance development process is too bureaucratic and that’s part of the reason that the cost is high, FDA should fix that.  For government to work effectively, agencies must be able to efficiently amend out-of-date laws. FDA staff has been complaining for years that the guidance development process is too bureaucratic, yet no one does anything about it. I’m not sure who FDA is expecting will come in and fix that process for them.


FDA is spending a tremendous amount of time and energy on its proposed precertification program for software, and frankly I’m glad that the agency is interested in improving innovation. But as compared to the time and money that it has taken and will continue to take to implement that program, it would be a very modest step indeed for the agency to simply correct the information on its website.

This is not the first time we have faced the problem of FDA putting inadequate priority on guidance development. Back in the 1990s, FDA preferred not to put guidance in any formal writing, but rather simply announce its interpretations during speeches or in industrywide letters. FDA also preferred not to ask for public comment, and frankly liked the flexibility of the more chaotic system. In 1994, I had to file a citizen's petition asking the agency to adopt what we would later call Good Guidance Practices. It seems the time has come for FDA to take a new look at how it develops and communicates policy in order to make sure that it is giving timely and accurate information to the regulated community. The current system is simply not working well — and would-be innovators are paying the price.

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