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The agency said manufacturers must provide evidence in their conformity assessment applications that their Quality Management System has been implemented in harmony with ISO 13485:2016. Read More
The agency may consider granting exemptions to trials of implants aimed at repairing catastrophic spinal damage or lost limbs if sponsors can show in their protocols that their trials approximate “realistic home-use environments.” Read More
Animal-derived materials have an important role in medical devices, but they “may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured,” the agency said. Read More
FDA Commissioner Scott Gottlieb and CDER director Jeff Shuren announced plans to promote device innovation and safety in 2019 using new premarket pathways as well as new safety and performance criteria. Read More
The FDA is planning to exempt certain unclassified devices from premarket notification requirements, according to an updated guidance from the agency. Read More
Australia’s Therapeutic Goods Administration issued two new guidances, one proposing a regulatory framework for personalized medical devices and the other on regulation of software, including software as a medical device (SaMD). Read More