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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
The FDA rapped Newton, North Carolina devicemaker Sarstedt after a June 28 to July 2, 2018 inspection revealed deficiencies in its document change and labeling procedures. 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
The FDA hit Imaging Biometrics with a Form 483, calling the Elm Grove, Wisconsin healthcare software developer out for its medical device reporting procedure and complaint records. Read More
The FDA cited Acorda Therapeutics’ Chelsea, Massachusetts manufacturing facility for its handling of discrepancy investigations observed during a June 4-18, 2018 inspection. Read More
The U.S. and the EU have pledged to cooperate to ensure that electronic database specifications for unique device identifiers (UDIs) are in alignment, according to the European Commission. Read More
The Medical Imaging & Technology Alliance is calling on the FDA to establish a framework that distinguishes between servicing and remanufacturing activities for medical imaging devices. Read More