April 8, 2019 By Danielle Kirsh FDA recommendations from the annual Human Factors and Ergonomics Society symposium
March 26, 2019 By Danielle Kirsh FDA reviews requirements for nicotine replacement therapy product labels
March 25, 2019 By Danielle Kirsh Dutch regulators explain no-deal Brexit impact for medical device companies
March 21, 2019 By Danielle Kirsh Taking a more rigorous approach to investigating fatal medical errors in the U.S.
March 15, 2019 By Danielle Kirsh Australia medical device regulators prepare Brexit contingency plans
March 13, 2019 By Danielle Kirsh U.S., Canadian regulators warn potential medical device shortages after Sterigenics shutdown
March 12, 2019 By Danielle Kirsh Brazil ANVISA launches notification pathway for low-risk medical devices and IVDs
March 2, 2019 By Danielle Kirsh Safeguarding against no-shows and late participation in medical device usability testing
March 1, 2019 By Danielle Kirsh Brazil to implement ANVISA Class I medical device notification pathway
January 31, 2019 By Danielle Kirsh FDA final guidance on safety and performance 510(k) medical device registration