How are clinical trials conducted for medical devices?

However, for medical devices, especially those that require a surgical implant, it is not appropriate to insert the devices into healthy subjects. Instead, device trials may initially be conducted in a smaller “pilot” population with the disease or condition being studied, before moving into the larger “pivotal” population.

What is an Investigational Device Exemption ( IDE )?

What is an Investigational Device Exemption (IDE)? FDA approval of an IDE is required for US human study of a significant risk device which is not approved for the indication being studied. Device trials are unique • Trials tend to be smaller than drug trials

What are the different types of IDEs for medical devices?

Types of IDEs • Pivotal study – Generally intended as the primary clinical support for a marketing application – Designed to demonstrate a “reasonable assurance of safety and effectiveness” – Endpoints and sample size statistically driven – Designed to assess both safety and effectiveness – FDA review is much more complex

Who is the principal investigator in a medical device trial?

In a medical device trial, the person administering the device is typically the principal investigator. Differences in who has greater responsibility. In a drug trial, the patient typically has a higher responsibility for taking the drug as required.

What makes a medical device an investigational device?

An investigational medical device is one that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device. 3. How are investigational medical devices classified?

What do you need to know about investigational device exemptions?

Clinical evaluation of devices that have not been cleared for marketing requires: an investigational plan approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA;

What does experimental surgery do at McGill University?

The Experimental Surgery Department is responsible for the administration of the graduate programs and allows excellent opportunities for training under the supervision of professors located in the Research Institute of the McGill University Health Centre or other McGill teaching hospitals.

What can you do with an Experimental Surgery degree?

Experimental Surgery offers graduate-level training leading to an M.Sc. or a Ph.D. degree. At the master’s level, in addition to the core program, those who are interested have a new opportunity to choose a concentration in Surgical Innovation, Surgical Education, or Global Surgery.