Pearl Pathways is proud of employee Heidi Strunk, as she earned a publication in the RAPS online journal Regulatory Focus. The article is located on RAPS.org (Login and Password required) and is entitled “Types of In Vitro Diagnostics: Clearing Up the Confusion.” By...
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...
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
