The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health

“The FDA continues to explore new approaches to promote greater safety of medical devices.

Today, we’re announcing the release of a discussion paper, Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework, an important step in our ongoing work to improve patient safety and awareness of the materials used in medical devices.

This discussion paper follows an Immunology Devices Panel Advisory Committee meeting held in November 2019. The meeting convened experts and the public to evaluate the safety of specific materials used in medical devices as well as to discuss the current state of the scientific evidence pertaining to metals and metal alloys used in medical devices. The FDA described the state of the science in a September 2019 peer-reviewed white paper released for public comment. The meeting and white paper were part of FDA’s broader initiative to assess the safety of select materials used in some medical devices, in particular the potential for certain patients to develop ‘hypersensitivity’ or exaggerated immune and inflammatory reactions to select materials.

The release of this subsequent discussion paper is intended to foster discussion and solicit feedback from stakeholders, including patients, on how we can ensure patients and healthcare providers have access to more comprehensive information about the different materials used in and on devices. This will help to ensure that patients and providers are empowered to make well-informed decisions about whether or not an individual should use a particular medical device.

The discussion paper is a direct result of the information we received from the November 2019 advisory committee meeting. Our request for public feedback underscores the value we place on obtaining insight from stakeholders to help inform and shape our decision-making.

The FDA is pleased to be at the forefront supporting this era of medical device innovation while maintaining patient safety. We know that both work in tandem to bring access to safe and effective medical devices. Ultimately, this increase in transparency aims to minimize the potential for patient risk and have a profound impact on patient health and quality of life.”

 

Additional Information

• Today the FDA published a discussion paper, Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework, that provides an initial framework to stimulate discussion and solicit feedback from a variety of stakeholders on the scope of device-related materials information and the ways it could be communicated to the intended users.
• The safety of materials from which certain devices are manufactured or processed has generated substantial interest from stakeholders who want to be better informed regarding medical device materials and their impact on the benefits and risks of medical devices.
• The discussion paper further highlights considerations for labeling of medical devices as it relates to the material composition. The FDA is committed to ensuring that patients and healthcare providers have timely and continued access to safe, effective and high-quality medical devices and safe radiation-emitting products.
• The FDA is currently seeking stakeholder feedback on the consideration to include more specific materials information on user or tissue-contacting materials in labeling for devices. Devices on which comments are sought may include medical devices that are implanted or are intended to be utilized repeatedly.
• Comments may be submitted to the public docket here. Comments for consideration in the development of the report must be submitted by July 19, 2021

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