Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Member: $545.00Nonmember: $745.00
diagnostic devices (IVDs) drive a significant portion of clinical decision
making today. IVDs assist in the identification, diagnosis and monitoring
disease or other conditions and aid in the determination of states of health.
These products are also intended for use in the
collection, preparation and examination of specimens taken from the human body,
including, for example, blood, tissue, urine, saliva, cerebrospinal fluid, hair
and sweat. They play an ever-expanding role in the selection of
appropriate therapeutic interventions in healthcare delivery, especially with
the advent of “personalized medicine.” In vitro diagnostic products are
considered a subset of medical devices in the US and are regulated by the Food
and Drug Administration (FDA). Outside the US, in vitro diagnostic
products are regulated either as a subset of medical devices or through a
separate regulation specific to in vitro diagnostic devices.
This course provides a basic overview of IVDs, including an historical background
focused on regulatory requirements. It introduces key regulations and
guidelines necessary for effective product development. In addition, this
course describes IVDs, regulatory aspects related to IVDs’ performance
evaluation and testing, submission requirements for marketing authorization for
IVDs, and IVD postmarket considerations such as adverse event and malfunction
At A Glance
Upon completion of this course, participants should be able to: