What Exactly is my Test Article?
In this episode, Dr. Phil Smiraldo (NAMSA’s Senior Toxicologist) joins us to discuss the test article and the many challenges with identification and preparation. Throughout this discussion, we explore the many different types of test articles and help define what is considered patient contact and what is not. We also review how you can best work with your laboratory to define your test article preparation and make certain the test article definition is clear to the regulatory agency.
Listeners can expect to learn:
- How to easily define their test article
- Key points to consider when separating patient contacting and non-patient contacting devices
- The risks of including non-patient contacting components in an extract
“One of the things we thought we’d elaborate on today is how do I define my test article.” – Sheri Krajewski
“We are not going to jump into the GLP regulations and jump into that definition, but we will help define the test article as it relates to biocompatibility.” – Don Pohl
“I’ve even worked through a scenario for a particular device where the customer in fact came on-site to help take it apart.” – Phil Smiraldo
“This stuff [prep instructions] needs to be written down clearly so anyone can follow.” – Don Pohl
*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.
Also be sure to check out our Biocompatibility Strategy Navigator.