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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:
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