Biomaterials: Is there a better way for FDA to regulate them?

The medical device industry is pretty conservative when it comes to materials used in medical devices. That begs the question: Do we need a new FDA approval pathway for biomaterials? Mike Drues thinks the answer is “yes.” “It really will encourage companies to use new materials and not be hamstrung with materials that have been

Who got picked for FDA’s digital health pre-cert pilot?

FDA has announced the names of the companies selected to participate in its digital health pre-cert pilot – a first-of-its-kind program aimed to revolutionize digital health regulation in the U.S. Dr. Scott Gottlieb, FDA’s commissioner, announced the nine participants of FDA’s digital health software precertification pilot program (FDA Pre-cert) last week during his keynote address at the

Should the medical device industry pay user fees to CMS?

Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA? That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by

FDA’s CDRH reveals guidance plans for FY2017

CDRH is setting its goals along with the rest of us for the new year. The agency has published and prioritized its intentions for FY2017, starting with a list of new documents it intends to release in FY2017 (A-list). It has also shared a B-list of previously-issued final guidances for which CDRH would like feedback,