Following on from FDA clearance in 2018, a final order has been issued to classify Natural Cycles as a Class II medical device.
NEW YORK /PRNewswire/ -- The FDA (The Food and Drug Administration) has issued a final order to classify Natural Cycles as a Class II device. The FDA is a federal agency in the United States (US) that is responsible for protecting and promoting public health. In August 2018, Natural Cycles' application for De Novo classification as a Class II medical device was granted by the FDA, making Natural Cycles the first app cleared in the US as a form of birth control.
Following the 2018 clearance, Natural Cycles' classification as a Class II medical device has been in effect since the initial approval. The final order is the last part of the approval process that establishes the required special controls and officially codifies the new regulation for this type of technology. Since the initial FDA approval, Natural Cycles has been operating under these special controls.
"We are pleased that the FDA recognizes that digital health technologies can empower consumers to make better-informed decisions about their own health. As the first and only app to be cleared in the US as a form of birth control, this approval is setting the framework and guidance for future developments in this area," said Raoul Scherwitzl, PhD, CEO and co-founder, Natural Cycles. "We welcome the FDA's decision to encourage innovation while ensuring the safety and efficacy of digital health products, including mobile medical apps. Our mission at Natural Cycles is to pioneer women's health with research and passion, and this final milestone marks a very important step in that journey."
References
1. Berglund Scherwitzl E, Lundberg O, Kopp Kallner H, Gemzell Danielsson K, Trussell J, Scherwitzl R. Perfect-use and typical-use Pearl Index of a contraceptive mobile app. Contraception. 2017;96(6):420-425.
