Pearl Pathways is proud of employee Heidi Strunk, as she earned a publication in the RAPS online journal Regulatory Focus. The full article can be found on RAPS.org (Login and Password required) and is entitled “Types of In Vitro Diagnostics: Clearing Up the Confusion.”
By definition, all in vitro diagnostics (IVDs) for human use are medical devices. This is easily understood – however, IVD classification can become complicated with an abundance of acronyms. To clear up the confusion, this article considers six types of IVDs:
- Research Use Only (RUO)
- Investigational Use Only (IUO)
- Analyte-Specific Reagents (ASRs)
- Laboratory-Developed Tests (LDTs)
- Companion Diagnostic IVDs
- In Vitro Diagnostic Multivariate Index Assays (IVDMIAs)
There are a number of hurdles to bringing a new medical device to the market, but product classification does not have to be one of them. If you are involved in the development of IVDs, this is a must read article.
Read full article here on RAPS.org.