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:
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The final regulations that provide guidance on the excise tax imposed on the sale of certain medical devices, enacted by the Health Care and Education Reconciliation Act of 2010 in conjunction with the Patient Protection and Affordable Care Act.
This document provides interim guidance for infection control for healthcare facilities (e.g., hospitals, long-term care and outpatient facilities, and other settings where healthcare is provided).
The medical device excise tax is a feature of the Affordable Care Act. It is important to be knowledgeable about the tax and its effects.
This Special Fraud Alert focuses on the specific attributes and practices of PODs that OIG believes produce substantial fraud and abuse risk and pose dangers to patient safety.