The Healthcare Distribution Alliance (HDA) on Monday issued a guide to help the pharmaceutical industry in formatting and placing bar code labels on their products to comply with Drug Supply Chain Security Act (DSCSA) requirements for tracking products through the supply chain.   DSCSA was signed into law in November 2013 and outlines the necessary steps necessary to build and electronic, interoperable system to identify and trace prescription drugs distributed in ...

The US Food and Drug Administration (FDA) on Thursday finalized guidance first released in 2015 to clarify when direct marking of devices with a unique device identifier (UDI) is required. FDA requires a device to be directly marked with a UDI when the device is intended to be used more than once and intended to be reprocessed before each use. The guidance provides FDA's interpretation of the terms, "intended to be used more than once" and "intended to be reproces...

Millions of Americans are implanted with various medical devices each year, though the Centers for Medicare & Medicaid Services (CMS) still lacks the ability to track which devices prematurely fail or are recalled based on claims data. At a hearing Tuesday at the Senate Health, Education, Labor and Pensions (HELP) committee, Sen. Elizabeth Warren (D-MA) called on CMS to update the Medicare claims form to include a line for the unique device identifier (UDI) to kno...

The US Food and Drug Administration (FDA) is recommending the use of an existing data exchange standard for nearly all pharmaceutical and biological submissions. Background The agency, through its Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER), has decided to adopt the Logical Observation Identifiers Names and Codes (LOINC) as "part of a larger FDA effort to align the use of data standards for clinical research with ongoing ...

What do human factors engineering (HFE), unique device identifiers (UDIs) and restriction of hazardous substances (RoHS) have in common? More than one may think. At the recent 2014 RAPS San Francisco Bay Area Chapter’s annual educational collaboration with the ASQ Northern California Biomedical Division, attendees gathered to enhance their understanding of HFE, the requirements for UDI and the impact of the RoHS 2 Directive 2011/65/EU 1 aimed at devices currently under D...