The Food and Drug Administration Center for Devices and Radiological Health is soliciting feedback on how materials information about medical devices should be communicated to patients and healthcare providers. On May 20, 2021, the FDA published a discussion paper titled Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework. With a goal of stimulating discussion among stakeholders, the paper outlines several factors to consider for labeling devices so that providers can make well-informed decisions about which devices may be most appropriate for their patients.
The administration acknowledges that communicating materials information is challenging because of the variety and complexity of materials used in medical devices. To that end, the discussion is aimed at creating a labeling process that is consistent and easy for patients and healthcare providers to access and understand. “Given the importance of labeling, which is intended to provide patients and healthcare providers [with] appropriate access to information on the materials of devices with long-term exposure, CDRH believes that promoting greater clarity, predictability and consistency in the content and format of medical device labeling with respect to constituent materials could allow providers and patients to make better-informed decisions about whether or not to use a particular device.”
The CDHR initially considered four factors it believes are important to materials information labeling:
- Duration of implantation. Many implants are not intended to be removed. Devices that are not intended to be removed may pose additional risks should they require removal (e.g., additional surgical procedures and complications resulting from removal). In these situations, inclusion of the specific materials and/or constituents of the materials may be informative and relevant to stakeholders.
- Duration of contact. Although not always the case, generally, devices with longer durations or repeated contact may pose greater risks of eliciting an adverse reactions as compared to devices with more-limited contact durations (e.g., shorter than 30 days).
- Usefulness of labeling. Ideally, specific materials information included within labeling would be readily usable and understandable by stakeholders to inform decision-making.
- Diversity of devices. There is a wide diversity of medical devices, which includes many low-risk devices for which it may not be necessary or appropriate to provide specific materials information in the labeling. As such, CDRH does not think it is practical or least burdensome for manufacturers to provide labeling that includes specific materials information for all devices, regardless of risk.
The discussion paper provides possible naming conventions and other labeling considerations for seven categories of materials used in devices with long-term exposure (defined as greater than 30 days of contact): metals, polymers, ceramics, naturally derived materials from animal sources, naturally derived materials from nonanimal sources, composites, and manufacturing residuals.
Additionally, the paper requests feedback on whether healthcare provider labeling should include recommendations on the counseling of patients. For devices intended for use only by healthcare providers, including surgical masks and personal protective equipment, the FDA seeks input on labeling information that would be helpful to those users. The paper also requests input on whether devices should include labeling information for patients — specifically, a basic description of the device and a list of materials used in the device put in layman’s terms.
Seven specific discussion questions are offered to streamline feedback and comments:
- What factors might be considered in the development of a framework for medical device labeling where specific materials information could be considered important and relevant for informed decision-making by the patient or healthcare provider?
- Given the wide range of devices in use, for which types of devices could detailed materials information in labeling be appropriate and relevant for informed decision-making by the patient or healthcare provider?
- What information, if any, could be useful in healthcare provider labeling regarding materials information and/or patient counseling with respect to device materials, and are there any specific concerns related to how materials information may be conveyed in healthcare provider labeling (e.g., language, formatting)?
- What information, if any, could be useful in patient labeling regarding materials information, and are there any specific concerns related to how materials information may be conveyed in patient labeling (e.g., language, formatting)?
- Given the variety of different material types, and considering the examples provided in Appendices A and B, how might materials information (e.g., material type, naming convention) be presented in the most clear and consistent manner to healthcare providers and patients?
- What information is most important to provide to communicate potential risks of different types of materials?
- If there are any medical device materials that you use/are concerned about that do not fit into the material types noted in Section III (1)-(7) of the discussion paper, what are they, and how might they be addressed in medical device labeling?
The complete discussion paper can be found at the following link: https://www.fda.gov/media/148860/download. Interested parties may submit comments through a public docket on the Federal Register: https://www.regulations.gov, Docket No. FDA-2021-N0334. The FDA will consider all comments submitted to this docket before issuing subsequent documents or draft guidance. The last day to submit comments is July 19, 2021.