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Advisory
FDA Releases Proposed Rule on Unique Device System for Medical Devices
Oct 20, 2015
The FDA UDI ruling has finally arrived - the proposed rule has published. Please see the FDA website (www.fda.gov/udi) for a link to the proposed regulation. Highlights include a 120 day comment period to begin shortly, 6 months later a final ruling that will begin with Class III devices within 2 years, possibly sooner. Below is the FDA press release:
Products and Services Contracting, Data Standards, Distribution, Regulatory, Unique Device Identifier (UDI), Logistics
Advisory
Hospital Compare: CMS Suspends Display of Hospital-Acquired Conditions Data
Oct 20, 2015
Quality advisory in response to the Centers for Medicare & Medicaid Services (CMS) announcement that it has suspended plans to add data on hospital-acquired conditions (HAC) to Hospital Compare, citing an error in the agency's data file used to calculate the HAC measures. Download
Analytics & Research, Benchmarking, Data Standards, Legislative, Regulatory, Sustainability, Performance Metrics
Advisory
New Guidance on Humidity Levels in the Operating Room
Oct 20, 2015
This Issue
Data Standards, Financial Management, Materials Management Information System (MMIS), Regulatory, Medical Device Technology