FDA Will Hold Advisory Panel Meeting In Fall On Metal Implant Reactivity
US FDA Commissioner Scott Gottlieb and device center director Jeffrey Shuren reminded the public on March 15 that materials in devices – including metals in orthopedic products and defibrillators – can cause reactions in some patients. They said the agency needs to do "more work” on patient responses to metal implants and other biomaterials, and announced an FDA advisory panel meeting this fall on reactions to metals.
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Nitinol, a nickel-titanium alloy ubiquitous in medical devices, is getting more scrutiny from US FDA in a recently released draft guidance. As safety concerns have arisen in the past few years over biocompatibility of certain materials in implanted products, the agency is asking device makers to provide additional information on nitinol in their device submissions.
Device-makers will have to take a more proactive approach to understanding the safety of biomaterials they use for their implanted devices, and how these materials might affect patients during post-market use, industry attorney Michele Buenafe of Morgan Lewis & Bockius LLP told Medtech Insight in a March 18 interview.
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