Tag Archive: unique device identifier

Jul 27 2012

FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

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Jul 09 2012

Unique Device Identifiers: It’s the Law, Almost

When the FDA Amendments Act was signed into law in 2007, one of its many tasks was to create a Unique Device Identifier (UDI) system.  On 03 July 2012, the FDA released the proposed rule for UDIs. The UDI is a code, similar in theory to a barcode, that will be printed on each device …

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