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Manufacturers can get earlier access to the market under a new pilot program launched last week in South Korea that unifies the country’s medical device approval review process and the health technology assessment. Read More
A Senate report that followed an investigation by Sen. Patty Murray’s (D-Wash.) office has found that the FDA’s regulatory system for monitoring the safety of devices failed to quickly identify and resolve the spread of antibiotic-resistant infections linked to duodenoscopes. Read More
FDAnews held a webinar earlier this month in which three attorneys from Hogan Lovells, including partner Yarmela Pavlovic, explained the FDA’s direct de novo process. The following is adapted from that event. Read More
India’s medical device industry is urging the government to implement several policy measures — including tariff corrections and a new regulatory regime — to ensure the financial viability of domestic device manufacturing parks in the country. Read More