FDA Focusing More On Safety Of Device Biomaterials, Attorney Warns
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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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.
A long-awaited final guidance from the US Food and Drug Administration covering biocompatibility testing of medical devices adds several new sections compared with a draft version issued in April 2013, including recommendations for taking a risk-based approach to biological testing of materials, chemical testing, and test-article preparation for devices with nanotech and submicron components1-3.
The White House will be spending $86m to provide tens of millions of coronavirus masks to poorer American households.