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The U.S. Food and Drug Administration’s new custom device exemption does not apply to 510(k)-cleared devices that are modified but still retain their original intended use and could be clinically studied, the agency clarifies in a draft guidance. Read More
Devicemakers must include information on potential pediatric use in most new device submissions under a U.S. Food and Drug Administration final rule that takes effect April 10. Read More
Manufacturers of partial hip, knee and shoulder implants reclassified from Class IIb to Class III may use summary technical reports as interim evidence for inclusion of their devices in the Australian Register of Therapeutic Goods, the Therapeutic Goods Administration says. Read More
Russian regulators are struggling to create guidance that will implement device registration rules that took effect in January 2013, but have yet to be fully enacted. Read More
Chinese inspectors will focus their reviews on production technologies, raw materials, adverse event reports and a company’s past inspection track record when they conduct quality inspections. Read More
India’s Ministry of Health and Family Welfare said it will create a Medical Technology Assessment Board to evaluate existing and new technologies and accelerate production by local devicemakers. Read More
Sponsors of clinical trials in India must inform enrollees during videotaped informed consent sessions about potential payments resulting from adverse events, a draft guideline says. Read More