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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:

Products and Services Contracting, Legislation and Legislative Advocacy, Physician Preference Items (PPI), Regulations and Regulatory Advocacy, Suppliers, Procurement

Final Regulations on Taxable Medical Devices

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.