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The U.S. Food and Drug Administration is proposing a new, voluntary program to speed the approval of devices that address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions. Read More
Devicemakers often misuse voluntary consensus standards in premarket submissions, the FDA says, by using versions of standards that the agency doesn’t recognize or using consensus standards that don’t apply to their specific device or testing methods. Read More
CDRH brought in nearly 50 percent more device user fees in fiscal year 2013 than in 2012, according to the FDA’s quarterly report on MDUFA performance. Read More
Cook Vascular was handed an FDA warning letter for marketing the Cook Evolution RL and the Shortie RL Bi-directional Dilator Sheath Sets without marketing clearance or approval. Read More