The DivaCup holds the U.S. FDA (Food and Drug Administration) 510k Medical Device Number and the Health Canada Medical Device License. Diva International Inc. is also ISO 13485 Certified, which ensures the highest quality in production, packaging and distribution of The DivaCup. The Diva Cup is made of the softest medical grade silicone, which is latex-free, 100% hypoallergenic and odorless. For over 50 years, silicone has been safely and extensively used in products for the health care industry. Under the regulations, and because it is a personal hygiene product, it is suggested that menstrual cups should be replaced once a year.