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A container of gasoline stored next to orthopedic trays got devicemaker Medsource into hot water with the FDA and landed the firm a Sept. 24 warning letter for quality system deficiencies Read More
The FDA has offered its initial thinking on the best practices devicemakers can adopt when conducting animal studies in preparation for a possible IDE submission. Read More
The China Food and Drug Administration has issued four guidelines that give additional information for devicemakers awaiting good manufacturing practices inspections. Read More
With an eye toward information exchange and protecting public health, the UK’s Medicines and Healthcare products Regulatory Agency signed an agreement with India’s Central Drugs Standard Control Organization to increase collaboration on medical devices. Read More
Speaking at AdvaMed 2015, FDA Associate Director for International Affairs Kim Trautman renewed her call for participants in the International Medical Device Regulator Forum’s single audit pilot program, saying devicemakers have proven reluctant to join. Read More
While many stakeholders are excited about the 21st Century Cures Act recently passed by the House, industry should be mindful that the Senate version could be quite different. Read More
Peruvian health officials have amended regulations related to medical devices in a move that could prove beneficial for foreign and domestic manufacturers. Read More