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Advisory
FDA Releases Proposed Rule on Unique Device System for Medical Devices
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, Regulations and Regulatory Advocacy, Unique Device Identifier (UDI), Logistics
Advisory
Guidance on Humidity Levels in the Operating Room
New Guidance on Humidity Levels in the Operating Room
Data Standards, Financial Management, Materials Management Information System (MMIS), Regulations and Regulatory Advocacy, Medical Device Technology