By definition, all in vitro diagnostics (IVDs) for human use are medical devices. That much is easy to understand: however, classifying medical devices under the IVD umbrella can become complicated when the difference between each category is often unclear. There are...
In December 2012, Pearl IRB published a White paper, “What Could Proposed Changes to the Common Rule Mean to Sites, Sponsors and IRBs?” The Common Rule, also known as the Federal Policy for the Protection of Human Subjects outlines regulatory requirements for human...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
