This webinar is intended to help you get familiar with the Unique Device Identification (UDI) final rules, finally issued on September 24, 2013.
This webinar is further intended to help you effectively implement a unique device identification (UDI) system (UDI system). In particular, new changes in the final rules will be discussed, helping to save you an enormous amount of time, efforts and resources to achieve compliance and to remain compliant with the final UDI system requirements.
In 2007, Congress passed legislation directing the FDA to develop regulations establishing a unique device identification system for medical devices. The UDI final rules are intended to establish a system to adequately identify devices during use and distribution.
According to the finalized UDI rules, most medical devices distributed in the US are required to carry a Unique Device Identifier unless subject to an exception or alternative placement. The UDI system requires each device and each package to carry a UDI, the UDI of which should be provided in a plain text and in a form usable by automatic identification and data capture (AIDC) technology.
If the device is intended to be used more than once and intended to be reprocessed before each use, the UDI must be directly marked on the device itself.
The speaker will present how to implement the UDI system requirements in a CAC-SI manner.
Areas to be Covered:
Applicable Statute(S), Regulations and Enforcement Authority
UDI Development History
UDI Final Rules: Technical Requirements and Changes Made
When to Use a UDI and When to Discontinue Its Use
UDI System Requirements including Technical Standards
Requirements for a Unique Device Identifier
FDA Accreditation Process for an Issuing Agency including Suspension and Revocation
UDI Rules: Applicability
UDI Rules: Exceptions and Alternatives
Compliance Dates for the Applicable Requirements Over Seven (7) Years
Device Identifier Formats including Dates
Global UDI Database (GUDID): Technical Requirements (Data Format and Data Attributes)
Impact of the Final Rules to Many Business Areas/Processes
Changes in Device Design, Documentation and Manufacturing Processes
Practical, Actionable, and Sustainable Strategy: Good Practices to Implement UDI Systems Fast
Who will Benefit:
R&D Scientists, Managers, Directors, and VPs
Regulatory Affairs and Compliance Professionals
Clinical Affairs Professionals
Legal and Compliance Officers
Anyone Interested in the Subject