Both an arm prosthesis and a device used in transcatheter valve replacement will be regulated via class II, FDA announced this week.
A device used in cardiac surgery and a powered-arm prosthesis will both be regulated as moderate-risk, class II devices, US FDA affirmed in a pair of Oct. 17 Federal Register notices.
Both classifications stem from new device types that were previously cleared for market via the de novo process. Manufacturers of...
Partnership, positive communication and passion were all key in establishing a regulatory route for groundbreaking genetic testing technology for hereditary diseases. So said Fulgent Genetics’ executives interviewed by MTI about their technology’s development pathway.
The medtech industry, eagerly awaiting clear guidance on how healthcare data can be shared and help drive innovation, can have its say.
Electronic instructions for use are becoming increasingly prevalent in the medtech world, but so far in the EU do not extend to non-professional users.
Expect fresh scrutiny on skin substitute payments as the Office of the Inspector General found Medicare reimbursement for the products has continued its rapid increase despite fraud and abuse concerns.
