How does the FDA plan to address safety concerns regarding metals in medical devices?

The United States (US) Food and Drug Administration (FDA) is continuing efforts to evaluate materials such as metals, used in devices, to ensure their safety and efficacy.

Metals and alloys are frequently used in implanted medical devices and inserts such as dental amalgam fillings and implant. After reviewing adverse event reports of biological responses to metals used in devices, and following various concerns raised by patients and device users, the FDA has deduced that certain individuals may be predisposed to local or systemic immune inflammatory reactions on exposure to certain metals. Symptoms including fatigue, rash and muscle pain have been reported.

Pre-market submission requirements necessitate medical device manufacturers to submit biocompatibility data to prove that the materials they use in their device are safe in the human body or whether the associated risks are acceptable. The data can include test results from engineering, bench, design verification, human factors, animals and clinical studies. The FDA have posted two scientific reviews regarding biological responses to metal implants and dental amalgams, in which they have identified gaps and opportunities for further research related to evidence on immunological responses.

The FDA are engaging with scientists, patients, health-care providers and industry stakeholders, as well as utilising findings from post-approval and post-market surveillance studies, and scientific literature, to ensure that the benefits of the devices continue to outweigh the risks.

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