FDA Classifies Intravaginal Culture System in Class 2

The FDA issued a final order on Jan. 5 classifying the intravaginal culture system into Class 2 with special controls.

The order spells out specific risks and mitigation measures for the products, which are identified as a prescription device intended for preparing, holding and transferring human gametes or embryos during intravaginal in vitro fertilization or intravaginal culture procedures.

The decision went into effect on Nov. 2, 2015, following a request from INVO Bioscience for classification of the INVOcell intravaginal culture system (IDDM, Nov. 4, 2015).

Read the final order here: www.fdanews.com/01-16-ICS-Order.pdf. — Jonathon Shacat