The US Food and Drug Administration has put out a guidance document that establishes recommendations for notifying the agency of an interruption or permanent discontinuance of device manufacturing under section 506J of the FD&C Act.
This guidance is necessary because section 506J requires medical device companies to notify FDA, during or in advance of a public health emergency (PHE), of any interruption or discontinuance in their manufacturing that is likely to lead to meaningful disruption in the supply of that device in the US.
That’s a lot to take in, I know. The title and synopsis of this guidance raise a number of questions for MedTech companies. So, in this article I want to walk through some of the specifics of the guidance, as well as give you my two cents on it. Let’s dive in.
What is the background of this guidance?
Broadly speaking, the COVID-19 pandemic is the reason this guidance exists. The CARES Act was signed into law on March 27, 2020 when shortages of PPE and other devices were still very much on the mind of the government and the healthcare industry.
The CARES Act included an addition to the FD&C Act known as section 506J, which “provides FDA with new authorities intended to help prevent or mitigate medical device shortages” during or in advance of a PHE declared by the Secretary of Health and Human Services. The notification requirement this guidance addresses is a part of these new authorities. So, the FDA has put out this guidance document to help MedTech companies understand and fulfill their responsibilities.
Notification of a discontinuation or interruption won’t necessarily stop a shortage from happening, but the idea is that by having a complete understanding of the production landscape for critical devices during a PHE, the agency can use its powers to facilitate production, perhaps by removing red tape or fast-tracking marketing submissions.
Who needs to notify the FDA about their devices?
You can find the entire list of 506J devices on the FDA’s website, but they fall into two categories:
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Devices that are critical to public health during a PHE, including those that are life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery;
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Devices for which FDA determines information on potential meaningful supply disruptions is needed during, or in advance of, a PHE.
It is the legal manufacturer of these devices that is required to inform FDA of a discontinuance or interruption to manufacturing. Just remember, the “manufacturer” in this case is the entity that holds the device marketing authorization or, if a marketing submission is not required, the entity responsible for listing the medical device under section 510(j) of the FD&C Act. So, even if you are using a contract manufacturer, you are still required to notify FDA.
In fact, the guidance states that the legal manufacturer is “responsible for ensuring the contract manufacturers, supply chain partners, or other entities provide them with sufficient notice and information to fulfill their notification obligations under section 506J.”
What counts as “in advance” of a PHE?
“During a PHE emergency” is self-explanatory, but the phrase “in advance of” leaves more room for interpretation. Fortunately, FDA has attempted to define it more narrowly within the guidance document.
Here’s what the agency has to say:
If certain conditions exist prior to the occurrence of an outbreak or natural disaster that signal the potential for such event to occur and that may lead to the declaration of a PHE, FDA considers such conditions to be “in advance of a public health emergency.”
However, this does not mean you must be eternally vigilant for any sort of “signal” that a PHE may be coming down the line. FDA states that once the agency becomes aware of conditions that are in advance of a PHE, they will notify manufacturers to alert them of the situation and the applicability of 506J.
Keep in mind, though, whether or not a PHE is actually declared later on is immaterial to your responsibilities. So you are not retroactively off the hook for failing to notify FDA of an interruption or discontinuance if a PHE is never declared.
Is FDA going too far with this guidance?
Now, it is worth taking a step back and looking at this guidance and what it asks from a high-level. For me, two things stand out.
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Requiring manufacturers to notify the FDA about supply chain issues feels like unnecessary interference in how companies run their businesses. The government is essentially forcing private entities to divulge sensitive operational details that could be exploited by competitors or create market uncertainty. Businesses are already feeling pressure to maintain profitability, innovate, and manage their operations. Adding this layer of mandatory reporting, particularly one that could expose vulnerabilities, feels like a violation of their autonomy.
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The guidance feels like a potential pathway for public disclosure of shortages, which could cause panic buying or a loss of trust in certain brands. The free market has mechanisms to address supply and demand. Forcing transparency might actually worsen the problem by stoking fear or speculation, which distorts market dynamics.
However, there is also a fairly compelling counterargument—that the potential risks to public health trump the need of companies that supply critical devices to keep all their business intel to themselves. When I started this conversation on LinkedIn, I got a thoughtful reply from Stephanie Dickson (an excellent resource on Regulatory Affairs, by the way), who pointed out that FDA can do more than just affect submission timelines:
If we recall that formula shortage in 2022... FDA took certain actions that helped the supply chain - like conducting expedited reviews and exercising enforcement discretion for certain infant formula requirements - which increased the number of manufacturers able to supply infant formula to the US.
From this angle, the ability of FDA to have a holistic overview of the production (or lack thereof) of critical devices during a PHE is extremely important for ensuring their availability. This is certainly the spirit of the law. Whether it is being carried out in the best way is still up for debate.
I know this is an argument with a lot of different facets and everyone will see it in different ways depending on their political and economic orientation, so I’ll stop here, hopefully having made everyone equally mad along the way.
How can MedTech companies prepare for their notification responsibilities?
The biggest issue I see when we look at this notification responsibility is the necessary communication between manufacturing and regulatory affairs. In most companies, these are not two departments that are typically used to sharing a lot of information with each other.
Your master planner in a manufacturing facility will probably not have this 506J requirement on their radar. It’s unlikely that they’ll independently think to themselves, “Oh, we’ve got a shortage coming up, so I need to notify regulatory so they can notify FDA.”
So it’s important to set up those lines of communication, almost like a phone tree, that are ready to be used when there is a PHE or the possibility of one being declared.
Every manufacturer’s regulatory department should be doing their due diligence on this issue and determining whether any of the company’s products are on the 506J list. If there are products on the 506J list, then you need to put procedures in place for notifying FDA. And finally, people need to be trained on this. Manufacturing needs to be trained to recognize what will count as a meaningful disruption and what they need to do at that point.
All of that needs to be articulated in your SOPs so that when the moment comes, everyone knows exactly what they need to do. You don’t want to be in a situation where a hurricane is bearing down on your facility and the ball is being dropped on notifying FDA.
Make sure everyone is on the same page with Training Management from Greenlight Guru
When regulations change, responsibilities change. And if you are building out new SOPs for those responsibilities, then you need to ensure everyone who will use them is properly trained. Not only is it good practice for your business, it’s also a regulatory requirement under 21 CFR Part 820.
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