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Advisory
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, Data Standards, Distribution, Regulations and Regulatory Advocacy, Unique Device Identifier (UDI), Logistics
Letter/Comment
Global Unique Device Identification Database (GUDID) Draft Guidance for Industry
This page provides information about submitting data to the database for device Labelers, entities responsible for providing the data to the GUDID.
Benchmarking, Products and Services Contracting, Distribution, Financial Management, Lean/Six Sigma, Strategic Planning
Letter/Comment
IRS Issues Final Rule Implementing Medical Device Excise Tax
An announcement of the Final Rule issued by the IRS.
Capital Equipment, Distribution, Regulations and Regulatory Advocacy, Procurement