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.
Interim Guidance for Infection Control for Care of Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection in a Healthcare Setting
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). Download Now
AHRMM Member Advisory: Medical Device Tax Next Steps Background: The medical device excise tax is a feature of the Affordable Care Act. It was implemented by the IRS as of January 1, 2013. The 2.3 percent tax is expected to provide an estimated $20 billion in tax revenues over 10 years to help defray the cost of providing health insurance coverage to some 32 million Americans.
This special fraud alert addresses physician-owned entities, frequently referred to as physician-owned distributorships or 'PODs,' that derive revenue from selling, or arranging for the sale of, implantable medical devices ordered by their physician-owners for use in procedures the physician-owners perform on their own patients at hospitals or ambulatory surgical centers (ASCs).