In the Know

FDA Considers How to Evaluate the Safety of the Materials Used in Medical Devices
October 25, 2019
Alerts
Arnall Golden Gregory LLP

On September 30, 2019, Jeff Shuren, Director of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) issued a statement to announce the most recent updates to the agency’s attempts to evaluate the safety of the materials used in medical devices. The statement follows Director Shuren’s March 2019 announcement, which stated that a growing body of evidence suggests that some patients may have a predisposition to a biological response, such as an immune or inflammatory reaction, to certain types of materials in implantable or insertable medical devices. The reaction, however, may not develop until years after implantation and, therefore, the predisposition may be difficult to detect in clinical trials.

The March statement also included an overview of the agency’s initiatives to further the understanding of how certain types of devices and materials used in devices interact with the body, including breast implants and metals or metal alloys used in devices. The agency stated that it would convene an Advisory Committee meeting this Fall to discuss metal implants and gain a broader understanding of the use of metals in devices and learn more about safety concerns. In his September statement, Dr. Shuren announced that the Fall Advisory Committee meeting will be held November 13-14, 2019, and will be an Immunology Devices Panel meeting of the Medical Devices Advisory Committee.

As background, FDA reviews information about materials used in the composition of the medical device during the premarket review process to assess if there is a potential adverse biological response that would result from the medical device’s component materials coming into contact with the body. FDA also requires companies to submit biocompatibility evaluations to address the risks posed by the potential presence of harmful chemicals. In 2016, the agency finalized an updated guidance for industry about what the agency looks for in biocompatibility evaluations to ensure manufacturers have adequately assessed the potential for the device to cause an adverse biological response in a patient.

Highlights

  • The Advisory Committee meeting is meant to further the agency’s evaluation of materials used in implantable devices and engage experts to provide input on the types of scientific information the agency should consider in both premarket review and post-market surveillance.
  • Panel participants will look at certain patients with implants that contain select metals or metal alloys to assess the potential for the patient to develop immune and inflammatory reactions to the device and whether current biocompatibility standards are adequate.
  • The panel will provide feedback on the types of scientific information, whether for premarket review or post-market surveillance, that FDA should consider when evaluating metal-containing implants and dental amalgams.
  • The panel will evaluate potential gaps in scientific knowledge to identify the additional studies that may need to be conducted to mitigate risks.
  • The meeting will discuss how advances in immunology and related emerging and evolving scientific data may be able to help address certain risks to specific patients, e.g., helping to identify patients who are part of a small subset at an increased risk of experiencing a hypersensitivity response to a device and ways to mitigate the risks through, for instance, testing the patient prior to implant.
  • The September statement announced that the agency posted two scientific reviews that were written by FDA staff in advance of the meeting.
    • the first review summarizes the current scientific knowledge regarding different aspects of metal implants, including how the structure and function of these devices are impacted by the body’s tissues, muscles and blood supply and how the metal components wear over time and interact with the body’s immune cells.
    • the second review provides an updated assessment of the latest literature and data on potential risks reported to be associated with dental amalgam.
  • The agency stated that it is interested in hearing from stakeholders and learning more about their perspective on the reviews, and looks forward to discussing them and hearing feedback at the November public meeting.

AGG Observations

  • The announcement and the Advisory Committee meeting signify FDA’s continued focus on the safety of materials used in medical devices, and the agency’s interest in public input on ways to monitor and evaluate safety concerns.
  • As a result of the agency’s findings, there may be increased premarket or post-market surveillance activities for certain types of devices containing specific materials.

The Advisory Committee meeting will be open to the public, and comments received on or before October 28, 2019, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA.

For questions, please contact Alan Minsk or Genevieve Razick.

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