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As part of its efforts to reduce regulatory burdens on devicemakers and to implement provisions of the 21st Century Cures Act, the FDA issued a final… Read More
The Supreme Court ruled that the industry should comply with the summary of safety and clinical performance required under the EU’s 2017 Medical Device Regulation. Read More
Australia’s Therapeutic Goods Administration released findings from a public consultation on proposed regulatory changes for personalized and 3D printed medical devices and said, based on the stakeholder feedback, it decided not to implement regulatory changes for the devices at this time. Read More
Health Canada is making further reductions in audit times for its Medical Device Single Audit Program for smaller companies with lower-risk products. Read More
The FDA rejected a push to impose additional regulations on third-party servicers of medical devices, saying there is insufficient evidence to justify imposing new regulatory requirements. Read More
FDA Commissioner Scott Gottlieb offered more perspective on new initiatives the agency is undertaking to improve medical device safety in remarks at the FDLI annual conference in Washington, D.C. Read More