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When applying CLIA categorization of diagnostics, CDRH plans to alert sponsors to the categorization within two weeks of a positive marketing decision, the agency says. Read More
Wright Medical’s Augment Bone Graft is once more on the road to FDA approval, following the agency’s agreement to accept a further PMA amendment on the product. Read More
Boston Scientific’s Rebel Platinum Chromium Coronary Stent System has gained CE Mark approval for patients with coronary artery disease, the devicemaker said Wednesday. Read More
Devicemakers should note whether changes to premarket approval devices were due to enhancement, product complaints or adverse events when preparing their annual reports to the U.S. Food and Drug Administration, according to guidance issued Feb. 10. Read More
Medtech companies that make modest improvements to their products will, in most cases, not need to file a new 510(k) with the U.S. Food and Drug Administration, a Feb. 25 report to Congress says. Read More
Devicemakers planning a premarket approval application or product development protocol should take advantage of presubmission meetings with the U.S. Food and Drug Administration to pin down exactly what data the agency expects to support safety and efficacy of a new product. Read More