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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