ARTICLE SUMMARY:
In this week’s roundup: EU policymakers are optimistic about picking up the pace in aligning standards with the MDR; FDA takes steps to address COVID-19 mutations in diagnostics; a roundup of personnel exits and appointments at FDA’s device center, CMS, and AdvaMed; a global check-in, including Australia and Canada news, and more to watch.
Following a serious setback last year in efforts to formally link consensus technical device standards with compliance to the oncoming EU Medical Device and IVD Regulations, European policymakers are optimistic they can achieve a course correction by this spring, before MDR fully applies in May. That news leads off the latest edition of Pathways’ Picks.
