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:
Knowledge Center
Filter your results:
Type
Topic
3 Results Found
Oct 20, 2015
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