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“We do not want to imply that all other decisions of the agency that do not fall within section 517A of the FD&C Act are not significant,” a new proposed rule states. Read More
The Apex system “offers surgeons the greatest range of locking options of any intramedullary nail on the market, allowing tailored patient care,” the company said. Read More
The FDA said in a new draft guidance a “least burdensome” approach should be applied throughout the medical device total product lifecycle, rather than just in premarket activities. Read More
The FDA finalized a more detailed “leapfrog guidance” on additive manufactured, or 3D-printed, medical technologies, outlining its latest thinking on technical considerations. Read More