US medical device regulators are planning more focused evaluations of materials used in the manufacture of medical devices for safety issues.
According to a US FDA announcement, the agency acknowledges that despite current safety measures in place for certain implantable devices, “more work needs to be done” to address inflammatory reactions and other health conditions some patients experience after being implanted with these devices.
FDA specifically mentions breast implants as well as metals in devices, animal and innovative material components of devices such as metal-on-metal hip implants as warranting further assessment.
Modernizing the regulatory framework pertaining to the FDA’s review of medical device materials requires a multi-step approach. FDA may gather input from patients, device manufacturers, researchers and physicians to learn more about their concerns and ideas for how the FDA should proceed.