FDA is seeking feedback on plans to include more specific information on materials used in devices with long-term exposure such as breast implants and metal-on-metal hips.
The agency began evaluating the topic in 2019, culminating in a public meeting late that year, but updates stopped as the COVID-19 pandemic ramped up. Now, FDA has returned with a series of questions intended to inform the creation of a new regulatory framework.
FDA wants feedback on the types of devices that should be subject to more comprehensive labeling requirements, as well as how the information is conveyed to patients.
Several classes of medical devices with long-term exposure to patients have been the focus of major safety concerns in recent years. FDA highlighted metal-on-metal hips, breast implants and female sterilization devices, specifically Essure, as examples in its explanation of why it is planning to revise its approach to labeling.
The overarching goal of the proposed regulatory framework is to give patients and healthcare providers more information on the materials used in certain medical devices to support more informed benefit-risk decisions. Exactly what that means in practice is still up for debate.
In planning the framework, FDA has identified several factors it deems important. FDA sees devices that are not intended to be removed as posing additional risks that may justify the provision of information on the materials they contain. Similarly, FDA views the length of time a medical device is in contact with a patient as another correlate of risk and defines 30 days as long-term exposure.
FDA wants to know what types of devices the industry and other affected groups think should come with more detailed materials information. The agency is also seeking feedback on whether labels should list all materials "that could reasonably be bioavailable," a caveat that would free companies from the need to list internal components including electronics.
Several pages of the discussion paper outline FDA’s thinking about different materials, such as metals and ceramics. FDA addressed each material individually as they "typically have different naming conventions and considerations." For each material, FDA offers a view on what naming convention may work best, for example by stating the names of metals may be more informative than their chemical symbols. Under that proposal, labels would list "gold" rather than "Au".
Industry representatives expressed a willingness to work with FDA on labels and supported patients' and doctors' "right to know" the ingredients used in their products at the 2019 meeting. FDA accepts that the push for transparency will throw up difficulties, noting "the great level of scope and complexity of materials utilized in medical devices, which can be challenging to communicate in a clear and consistent manner."
The agency is accepting feedback for 60 days.