AHRMM

Articles

Cost Management, Financial Management, Regulations and Regulatory Advocacy, Procurement

Medical Device Excise Tax - What You Should Know

The Medical Device Excise Tax, a component of the Affordable Care Act, is approaching implementation at the beginning of 2013. The tax is intended to provide an estimated $20 billion in tax revenues to help pay for the expansion of health coverage to 32 million uninsured Americans. Healthcare supply chain leaders have until May 7, 2012, to comment on the way in which the Internal Revenue Service (IRS) intends to implement this new tax.

Products and Services Contracting, Data Standards, Distribution, Regulations and Regulatory Advocacy, Unique Device Identifier (UDI), Logistics

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: