Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome

Regulatory NewsRegulatory News | 20 April 2022 | By

Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.
 
In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen before and during a public health emergency (PHE) under section 506J of the Federal Food, Drug, and Cosmetic Act. [Related: FDA seeks comment on device shortage reporting guidance, Regulatory Focus, 10 January, 2022]
 
Medical device lobby group AdvaMed said it is concerned the FDA may be biting off more than it can chew with the amount of data it wants from companies, according to the group’s comments to the draft guidance docket.
 
“We believe the scope of requested information is too broad and in some cases requests information that is duplicative of information the agency already maintains,” AdvaMed wrote. “Requesting a manufacturer, who may at the time be responding to a product shortage, to gather information already available to FDA is inconsistent with the agency’s least burdensome principle.”
 
“Indeed, it pulls company teams away from the important task of addressing shortages of a critical product,” AdvaMed added.
 
Instead, FDA should work directly with manufacturers to mitigate specific supply issues rather than request duplicated information that may or may not be relevant to the situation, AdvaMed wrote.
 
AdvaMed also said that instead of asking manufacturers to broadly supply information on potential devices that may be facing shortages, the FDA should provide procodes for specific devices that are subject to 506J reporting requirements.
 
The group is concerned that, despite the agency’s best attempts, it will not always be clear what products meet the 506J standards for reporting and so it should be the agency’s responsibility to create a list of products that it wants data on to prevent shortages.
 
“Confusion over the scope of devices subject to the reporting requirements may lead medical device manufacturers to: (1) Overreport, taking away significant and valuable company resources from the important task of mitigating supply limitations, which is counterproductive; (2) overwhelm FDA’s new medical device supply chain operation; (3) provides no value where a device shortage does not exist; and (4) is inconsistent with FDA’s least burdensome principles,” AdvaMed argued.
 
The Medical Imaging and Technology Alliance (MITA) had similar concerns and noted that it thinks the guidance should have a significantly narrower scope and more strictly align with the original legislative intent.
 
“Advancing new policies on interruptions or discontinuations should be rooted in public health and patient safety,” the group said. “We are concerned that the Agency has taken an overly broad interpretation of the legislation and will require manufacturers to file reports on devices that are not relevant to a given PHE or in cases in which a meaningful disruption has not actually occurred.”
 
As a result, MITA also says the guidance could lead to over-reporting from manufacturers that not only would overburden medtech companies but also the FDA. Like AdvaMed’s suggestions, the group is recommending the FDA develop a narrower list of products that fall under the 506J requirements that industry can use to focus their efforts on.
 
“Over-reporting would not be in line with the ‘least burdensome’ principles that the agency is required to apply and would impact the effectiveness and efficiency of both stakeholders,” said the group. “We recommend that the agency publish and accept comment on a list of the specific devices it has identified as ‘critical to public health during a public health emergency, or for which FDA determines information on potential meaningful supply disruptions is needed during a public health emergency.”
 
MITA argues that medical device makers already make significant investments in processes and people with subject matter expertise to manage supplier challenges as part of their quality system requirements. Furthermore, manufacturers are continuously analyzing and addressing supply chain issues to ensure patients and providers have access to their products.
 
The group also says the need and considerations to track medical devices is very different from tracking pharmaceuticals where often there aren’t a lot of alternatives to a drug that is in short supply.
 
“Medical devices often contain hundreds or thousands of components— significantly more than drugs. There are often multiple device vendors, offering several versions or models of the same device types,” MITA noted. “Pharmaceuticals tend to have few (e.g., generic drugs) if any options of similar formulation.”
“If one device manufacturer experiences an interruption in production, there are usually other device models from that same manufacturer or a competing manufacturer that can fulfill market demand,” the group added. “In addition, healthcare facilities often have similar systems installed from multiple manufacturers that are available for clinical use (e.g., imaging systems).”
 
In the draft guidance, the FDA recommends that manufacturers try to notify the agency of shortages six months before a discontinuation or interruption to their product, and then update regulators every two weeks after that on the status of the product.
 
MITA says the timeline set by the FDA is arbitrary and would overburden not just the device makers but also the FDA with “irrelevant paperwork.”
 
“Instead, the agency should link reporting to measurable or meaningful actions directed to drive change in the shortage or disruption situation,” the group said.
 
The Bringing Real-world Insight for Device Governance and Evaluation (Bridge) Coalition and medtech company Cook Group, submitted similar comments to the FDA that the guidance was too broad and burdensome, and needs to be narrowed down. The also asked the FDA to provide information on what the agency plans to do with the data it aggregates from manufacturers beyond just keeping a tab on what devices may face a shortage.
 
“How will FDA triage incoming shortage reports to prioritize the most critical raw material shortages?” the Cook Group asked. “FDA should consider whether the critical device in shortage is from a sole source single supplier or whether there are similar alternative products in the market that will meet the needs of the public's health.”
 
The Bridge Coalition said it supports certain aspects of the draft guidance but is concerned the reporting requirements go well-beyond the 506J requirements and seeks data that is not actionable by the FDA.
 
“In particular, we support FDA’s willingness to accelerate reviews and inspections in ways to help mitigate actual or anticipated shortages. We also would urge FDA to be explicit that, in appropriate cases, it will exercise enforcement discretion as another regulatory tool,” the group said. “In our view, 506J is a target provision that intends to focus FDA and industry on situations in which FDA can actually add value. In any number of cases (e.g., labor shortages) remedies are outside of FDA’s purview.”

Draft Guidance

 

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