AHRMM

Articles

Benchmarking, Products and Services Contracting, Distribution, Financial Management, Lean/Six Sigma, Strategic Planning

Global Unique Device Identification Database (GUDID) Draft Guidance for Industry

By Center for Devices and Radiological Health, Informatics Staff, U.S. Department of Health and Human Services Food and Drug Administration, AHRMM

This page provides information about submitting data to the database for device Labelers, entities responsible for providing the data to the GUDID.

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

Medical Device Excise Tax - What You Should Know

By AHRMM

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.

Cost, Quality and Outcomes (CQO) Movement, Data Standards, Materials Management Information System (MMIS), Regulations and Regulatory Advocacy, Suppliers, Leadership

The Official Comment of AHRMM to the United States Department of Health and Human Services Food and Drug Administration (FDA) regarding Unique Device Identification for Medical Devices Docket No. FDA-2011-N-0090

By AHRMM

AHRMM comments to the FDA regarding an amendment to the UDI proposed rule to address the UDI implementation time frame required by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).