Here's a look at some of the top regulatory stories for medical device companies this week: Medicare's Sunshine Act changes could hit device makers in the pocketbook; Indian regulators clarify requirements for medical device registrations, clinical trials; US FDA publishes insight into 510(k) Substantial Equivalence determination process; Russian regulators preparing new medical device classification system?; FDA dings Spinal Elements for design changes, unreviewed claims
Medicare's Sunshine Act changes could hit device makers in the pocketbook
July 22, 2014 by Arezu Sarvestani
Centers for Medicare and Medicaid Services (CMS), Emergo Group, Food & Drug Administration (FDA), Spinal Elements
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