Unique Device Identifier (UDI)
Medical device manufacturers have been working hard to comply with the new Unique Device Identification (UDI) regulations from the FDA that are aimed at bolstering the safety of medical devices. The UDI system, which the agency says will be phased in over several years, is intended to improve…
This Awareness Brief provides a quick reference to the Draft Guidance for UDI Convenience Kits, released by the FDA in January 2016. The draft guidance defines the term “convenience kit” for purposes of compliance with UDI labeling and data submission requirements only.
Increasingly, the hospital and health care delivery system executives are viewing the supply chain as a strategic asset that can be leveraged to meet operational, clinical, and financial performance imperatives. This has not always been the case. For years, the supply chain was seen as little more…
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…
On November 21, 2013, AHRMM submitted electronically