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“The continuous, robust generation of evidence throughout the premarket and postmarket setting … is important to continuously refine our understanding of how medical devices are used and perform,” the agency said. Read More
Class IIb implantable devices, Class III devices, active implantable devices and certain in vitro diagnostics must be registered with the agency within four months of the UK’s exit. Read More
China’s State Council unveiled a plan to drive down high prices for medical devices and substitute expensive imports with locally made products. Read More
Devicemakers were critical of the European Commission’s specifications for reprocessing single-use devices, with many comments raising concerns about specifications were released earlier this summer. Read More
The European Commission issued new guidance on when devicemakers operating in the EU need to issue Field Safety Corrective Actions and how they should prepare field safety notices. Read More
The appeals court said the district court correctly interpreted the “plain language” of how the cylinder “verifies” the nitric oxide being released. Read More
CDRH says the priorities will help improve the “safety, effectiveness, performance and quality of medical devices and radiation-emitting products.” Read More