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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
The medical device regulations become fully applied in May 2020. Some in the device industry believe that the regulations’ three-year implementation period is too short. Read More
The firm’s response to Form 483 inspection observations indicated quality audits were being performed, but “with poorly defined requirements,” the agency said. Read More