Since the 1930s, the Food and Drug Administration has required food manufacturers to list each ingredient in a food product by its common name.  What if FDA required the same for certain medical devices?  It soon may. 

On May 24, 2021, the FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper detailing a proposed framework to include specific information on materials used in medical device labeling.^[1]  The framework CDRH proposes is similar to that used for the ingredient lists of food labels and would label certain medical devices to identify the “ingredients” that are designed to be in contact with the patient for more than 30 days.  CDRH has requested that stakeholders provide feedback on its proposed framework by July 19, 2021. This alert summarizes CDRH’s proposed labeling framework, including its significance, and the potential litigation implications for device manufacturers.

How might device labeling change?

CDRH is considering requiring that healthcare provider labeling include (1) specific information on the material composition of a medical device; and (2) recommendations on how to counsel patients about the materials of the device.  Because not all devices designed for long-term use have patient labeling, CDRH is also considering requiring manufacturers to provide patient labeling, which may include, among other things, a “basic description of the device and a list of patient-contacting materials of the device in a manner that is easily understood.”^[2]

What medical devices may be subject to the proposed changes?

All medical devices that may be in contact with a patient long term (> 30 days).^[3]

Why is CDRH considering incorporating these labeling requirements for certain medical devices?

According to CDRH, “several high-profile safety concerns associated with certain medical devices with long-term exposure” have prompted “discussion in the stakeholder community of the materials utilized in these medical devices and their potential association with adverse events being reported to FDA.”  In 2019, CDRH responded by completing a scientific literature review of metal-containing implants and holding an advisory committee meeting to discuss potential immunological responses to metal-containing implants.  One of CDRH’s takeaways from the advisory committee meeting is that “it is important and beneficial for patient safety to have the device packaging and labeling include a list of the elemental composition of the device.”^[4] 

CDRH believes that this information will assist patients and providers in two key ways: (1) it will permit them “to make better informed decisions about which medical devices may or may not be most appropriate for an individual patient;” and (2) it will “facilitate identifying whether an immunologic/ hypersensitivity to a material in a device was the cause of adverse health consequences experienced by the patient in whom the device was used.”^[5]       

What factors did CDRH consider in developing its proposed changes to device labeling?

CDRH identified the following factors as important to its consideration of whether and how to include a list of a medical device materials in labeling for patients and healthcare providers:

• Duration of implantation – CDRH believes that permanently implanted devices may pose additional risks, such as the need for surgical removal
• Duration of contact – CDRH states that generally devices with longer duration or repeated contact are more likely to elicit an adverse reaction (eg, more than 30 days)
• Usefulness of labeling – CDRH wants the materials information to be readily usable and understandable by stakeholders to inform decision-making and
• Device diversity – CDRH does not think it is practical or necessary for manufacturers to include materials information for all devices, especially those that pose low risk.^[6]

What device materials would be listed in labeling?

For all devices designed for long-term use, CDRH is considering identifying all materials that could reasonably be expected to contact human tissue.  This means that some device materials may not need to be listed if, for example, they are in an encasement or have a protective coating designed to prevent tissue exposure.  CDRH proposes listing the constituents of the following materials: (1) metals, (2) polymers, (3) ceramics, (4) naturally-derived materials: animal sources; (5) naturally-derived materials: non-animal sources; (6) composites; and (7) manufacturing residuals.^[7] 

How would device materials be listed in labeling?

CDRH suggests that the way materials are listed in labeling may vary depending on the type of material at issue.  It proposes the following for each material type:

• Metals: CDRH proposes listing metals by their elemental name (eg, nickel) in descending order according to their prevalence in the alloy. CDRH is also considering whether to include trace elements.
• Polymers: CDRH is considering requiring that polymers be listed by both their trade name and chemical name along with any color additives. Additional specificity may be required for polymers or their components that have known toxicological risks (eg, residual catalyst, monomer, impurity).It also identified certain polymer-based products that may warrant providing additional information such as over-the-counter lubricants and devices designed to degrade in situ.
• Ceramics: CDRH is considering listing the elemental names of the materials in descending order based on their prevalence in the ceramic.
• Animal sourced materials: For animal sourced materials, CDRH is considering identifying the animal, tissue type, purity of the material, and the chemical names and other information about any processing reagents.
• Naturally derived non-animal materials: For the non-animal sourced materials, CDRH suggests including the type, species of the material, purity of the material, and the chemical names and other information about any processing reagents.
• Composites: CDRH defines composites as being comprised of two or more independent materials that maintain material phases. CDRH suggests identifying each material as described above.
• Manufacturing residuals: CDRH raises a concern with devices that are processed in the presence of other manufacturing materials or processing aids that could lead to contamination of the device materials at toxicologically significant levels. If the residual chemicals are not removed in the cleaning process, CDRH proposes identifying the residual chemicals.^[8] 

What is the potential significance of these proposed labeling changes?

Providing information that can help patients and healthcare providers make an informed decision on medical devices is usually a good thing.  But while listing the ingredients of food products may help consumers make better food decisions, it is questionable whether a similar framework will help healthcare providers and patients make better device decisions.  Some potential downsides of the proposed framework include the following:

• Materials choice is not always an option: While consumers may review an ingredient list and decide to avoid a food that contains a known allergy or other health concern, medical device patients often do not have this option. Without adequate counseling from healthcare providers, some patients may forego necessary medical care based on concerns about device materials that are not supported by the evidence. Additionally, it is not clear that CDRH’s proposed patient labeling would discuss results from clinical studies and biocompatibility testing, which are far more indicative of a device’s safe and effective use.
• A materials list is insufficient to assess potential risks: Listing materials in descending order based on their prevalence in the component part is insufficient to understand their potential for toxic health effects. To understand the toxicity risks of a material, a reader needs to know the rate the material escapes from the device compared to the protective health values for that material.
• A materials list may provide a false sense of security: The CDRH suggests that a detailed list of device materials may help healthcare providers make better decisions about which medical implants are best suited for a particular patient. But it is still unclear whether this is true. In fact, during the 2019 advisory committee meeting, discussed above, the panel members acknowledged that it is not currently possible to prospectively identify those patients that are at risk of developing an allergic or immune response to a particular material in a device. In the case of metal allergy, for example, case control and prospective studies have shown that not even a history of contact dermatitis to a metal or a positive patch test can predict whether a patient will develop contact dermatitis or other complications from metallic joint implants. Further, there is currently no known causal link between certain device materials and autoimmune disorders. Therefore, while it may be helpful for patients and healthcare providers to discuss the materials in a device, it may be too soon to suggest that considering such information will lead to better health outcomes.

What are the potential litigation implications for medical device manufacturers?

Manufacturers could experience an increase in adverse event reporting and related litigation when a material listed in the device receives media attention for unrelated health concerns.  The proposed labelling requirements will likely arm plaintiffs with new theories of liability relating to whether a manufacturer properly listed the necessary materials in the label.  They could argue, for example, that an omitted material should have been listed, because it was reasonably likely to contact human tissue or that a manufacturing residual should have been disclosed, because it existed at toxicologically significant levels.  Such theories would once again test preemption defenses.

How can DLA Piper help?

DLA Piper’s government affairs and regulatory team can help you provide meaningful and effective feedback to CDRH by the July 19 deadline, as well as counsel you on implementing any new labeling rules that may result.  DLA Piper also has a team of experienced litigators in the medical device industry who can help when litigation ensues.