The Medical Device Validation Handbook
161
Introduction
The Unique Device Identification (UDI) system
from the Food and Drug Administration (FDA)
aims to substantially reduce existing obstacles to
the adequate identification of medical devices
used in the US. By making it possible to rap-
idly and definitively identify a device and key
attributes that affect its safe and effective use,
the system could reduce medical errors that
result from the misidentification of a device or
confusion concerning its appropriate use. The
identification system allows for more accurate
reporting of adverse events by making it easier to
identify the device before submitting a report.1,2
Concern over patient safety was the primary
driver for the FDA to create its system. The
mandate for the agency to develop a UDI system
was required as part of the Food and Drug
Administration Amendments Act of 2007. The
final rule was published in September 2013 along
with draft guidance on Global Unique Device
Identification Database (GUDID). Subsequently,
the FDA released its final GUDID guidance
in June 2014.3,4 The rule is intended to address
concerns by healthcare providers and regula-
tory agencies about the lack of transparency in
the way manufacturers and distributors assign
item numbers (identifiers) to medical devices.
A manufacturer typically assigns a number to
its device. A distributor often assigns its own
different identifier before selling that same
item to the ultimate user, or Manufacturer A
and Manufacturer B use the same identifier for
the same type of device or completely different
items. This can confuse the end user, particularly
related to reporting adverse events and product
recalls. The UDI system is expected to help the
FDA identify product problems more quickly,
better target recalls, and improve patient safety.
This chapter reviews the UDI system and the
corresponding verification and validation (V&V)
issues facing every device labeler. Device man-
ufacturers will learn what steps are required to
comply with the FDA’s UDI regulation.
FDA’s UDI Regulation—The Basics
Several key aspects of the UDI final rule, 21
CFR Part 830, must be understood if an organi-
zation is to implement this regulation. Reading
the entire rule is highly recommended before
starting down the path of implementation. This
chapter outlines some key aspects.
FDA Unique Device Identification
Verification and Validation
Jonathan C. Bretz and Jay Crowley
11
161
Introduction
The Unique Device Identification (UDI) system
from the Food and Drug Administration (FDA)
aims to substantially reduce existing obstacles to
the adequate identification of medical devices
used in the US. By making it possible to rap-
idly and definitively identify a device and key
attributes that affect its safe and effective use,
the system could reduce medical errors that
result from the misidentification of a device or
confusion concerning its appropriate use. The
identification system allows for more accurate
reporting of adverse events by making it easier to
identify the device before submitting a report.1,2
Concern over patient safety was the primary
driver for the FDA to create its system. The
mandate for the agency to develop a UDI system
was required as part of the Food and Drug
Administration Amendments Act of 2007. The
final rule was published in September 2013 along
with draft guidance on Global Unique Device
Identification Database (GUDID). Subsequently,
the FDA released its final GUDID guidance
in June 2014.3,4 The rule is intended to address
concerns by healthcare providers and regula-
tory agencies about the lack of transparency in
the way manufacturers and distributors assign
item numbers (identifiers) to medical devices.
A manufacturer typically assigns a number to
its device. A distributor often assigns its own
different identifier before selling that same
item to the ultimate user, or Manufacturer A
and Manufacturer B use the same identifier for
the same type of device or completely different
items. This can confuse the end user, particularly
related to reporting adverse events and product
recalls. The UDI system is expected to help the
FDA identify product problems more quickly,
better target recalls, and improve patient safety.
This chapter reviews the UDI system and the
corresponding verification and validation (V&V)
issues facing every device labeler. Device man-
ufacturers will learn what steps are required to
comply with the FDA’s UDI regulation.
FDA’s UDI Regulation—The Basics
Several key aspects of the UDI final rule, 21
CFR Part 830, must be understood if an organi-
zation is to implement this regulation. Reading
the entire rule is highly recommended before
starting down the path of implementation. This
chapter outlines some key aspects.
FDA Unique Device Identification
Verification and Validation
Jonathan C. Bretz and Jay Crowley
11