Origins of FDA’s Discussion Paper

FDA’s discussion paper traces its origins back to several medical device mass torts of recent years, where it has been alleged that the materials used in the devices were related to reported adverse events. In response to these highly publicized claims, FDA held a public meeting of the Immunology Devices Panel in 2019 to discuss immunologic responses to metal-containing devices. The public submitted 463 electronic comments to the open meeting, including some from the medical device industry and physician and dentist associations, and most from patients and patient advocacy groups.13 The American Academy of Dermatology Association and the American Contact Dermatitis Association, a group representing 13,800 dermatologists, submitted a letter advocating for more transparent labeling of metal and non-metal components in medical devices in such a way as to protect trade secrets and encourage innovation. Patient advocate organizations requested a slew of changes including, among other things, labeling of materials, disclosure of material safety data sheets of component materials, no trade secret protection for implantable devices, extensive FDA-funded biocompatibility testing, and a new, more stringent regulatory pathway for approval of changes in material sourcing. The panel members also supported adding a “list of elemental composition” to device labeling.14 Although the Immunology Devices Panel was focused on metal-containing devices, FDA believes that a broader approach to material safety evaluation is warranted to promote greater clarity, predictability, and consistency across device labeling.15 According to FDA, the addition of materials to device labeling could facilitate better informed decision-making by patients and healthcare providers as well as facilitate identification of whether an adverse event is caused by a hypersensitivity or immunologic response to a device material.