Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and Diagnostic Emergency Use Authorizations in March 2021. Updated March 4.
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The recently-revised regulations to the Stark Physician Self-Referral Law have implications that extend beyond clinicians to medtech companies, particularly as the healthcare system increasingly evolves from volume to value-based programs. These expert healthcare attorneys explain why it is essential that medtech companies understand the full ramifications of this law’s current standards. By By Melissa Hudzik, Esq., and Jeff Weinstein, Esq., Wilson Sonsini Goodrich & Rosati.
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Sustained COVID-19 pressures continue to put IVDs in the spotlight—lab diagnostics were the most common topic of focus in February among global policy documents captured in Pathways’ Document Depot. A look at those docs and some other important releases from last month.