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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
China’s State Council last month approved the Medical Device Regulations (Amendment Bill), framework, paving the way for broad changes in device classification, adverse event reporting and monitoring of quality in device manufacturing. Read More