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Sponsors of medical devices should submit a declaration of conformity, certifying compliance with the standards on a list maintained by CDRH. Read More
An FDA-convened panel previously found the devices are associated with various complications, such as damage to blood vessels, nerves, and connective tissue. Read More
The company is required to make clinical trial data relating to Infuse publicly available through the government-run website ClinicalTrials.gov. Read More
“If we can’t work everything out, that’s fine. Let’s just put pen to paper on what we have worked out and maybe enter part of the puzzle,” said Shuren. Read More
The firm’s CAPA procedure failed to ensure that the information gathered about nonconforming products and quality issues reached the person responsible for dealing with them. Read More
The FDA’s regulatory process for manufacturers of new moderate-risk devices has “remained largely unchanged since it was first implemented 40 years ago,” Commissioner Scott Gottlieb said. Read More
The association pointed to the upwards 200,000 computers across more than 150 countries that were victims of the WannaCry ransomware attack earlier this year. Read More