Hello, I am Christine Lynn Lanning from Merck & Company, Incorporated.
I'm going to review the biological safety testing that is needed
to support development of medical device combination products.
Although much of this information is also applicable for a medical device,
I'm focusing the talk on MDCPs,
a medical device combination product,
which is the medical device in combination with a drug or biologic.
As such, this talk,
will introduce you at a high level to the requirements and testing that must be
satisfied to support the device aspect of the medical device combination product.
Specific testing requirements for the drug biologic component of the MDCP also
need to be satisfied and are covered in
other HS Talks, referenced at the end of this presentation.
One may ask, what is a medical device versus a medical device combination product,
often referred to as an MDCP.
A medical device is an apparatus or agent used to prevent or treat a disease or injury.
It may support life,
it may replace or support anatomy or a physiological process.
Some common examples that come to mind are thermometers, ultrasound, surgical equipment,
mesh, catheters, artificial joints,
and even hardware such as rods and screws that may be implanted.
It is important to note a medical device does not achieve
its primary action by pharmacological or metabolic means.
Now, a medical device combination product is the medical device
in combination with the active pharmaceutical ingredient or API,
that can be a drug or a biologic agent.
In this case, the device often is used to deliver the API to the intended site of action.
Some examples include an inhaler,
a prefilled syringe, or even a drug delivering implant.