US FDA statement on Evaluation of Materials in Medical Devices

The US FDA released a statement on the topic of materials used in medical devices as part of their effort to address potential safety questions.

Based on US FDA's evaluation and discussions with relevant experts and academia, some evidence suggests that a handful of individuals may be prone to developing an immune/inflammatory reaction when exposed to select materials.

Medical devices and their related materials mentioned in the statement includes:

  • Breast implants - silicone

  • Cardiovascular stents and guide wires - nitinol (a nickel and titanium alloy)

US FDA also mentioned concerns of animal materials used in medical devices such as additives used on device coatings and heart valves made from pig tissue. US FDA released a guidance on 15 March 2019 to provide recommendations to device manufacturers in effort to minimise the potential risk of transmitting diseases from animals to humans:

-Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices) Guidance Document

For more information on the statement, check out the following link:

-Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on efforts to evaluate materials in medical devices to address potential safety questions

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