自然週期（Natural Cycles）是美國首款也是唯一一款被FDA批准的節育型app。其2018年被批准後，以二類醫療器械上市。近日，FDA頒佈了對該小程序分類的最終指令，並完善了相關監管措施。
The FDA has issued a final order to classify Natural Cycles as a Class II device. The FDA is a federal agency in the United States 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.
FDA發佈了一項最終命令，將自然週期歸類為第二類設備。FDA 是美國負責保護和促進公眾健康的聯邦機構。2018年8月， Natural Cycles 申請 DeNovo 分類為 II 類醫療器械獲得 FDA 批准，使 Nature Cycles 成為美國首個獲得批准的應用程序，作為一種節育形式。
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.
在2018年許可授予後， Natural Cycles 歸類為二類醫療器械自首次批准上市以來一直有效。最後的命令是批准程序的最後一部分，該程序建立了所需的特殊控制措施，並正式編纂了這類技術的新法規。自 FDA 最初批准以來，自然週期一直在這些特殊控制下運行。
"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."
“我們很高興 FDA 認識到數字健康技術可以幫助消費者更好地做出關於他們自己健康的決策。自然週期公司首席執行官兼聯合創始人 Raoul Scherwitsz 博士說：“作為美國首個也是唯一一個以節育形式獲得批准的應用程序，這項批准為這一領域的未來發展建立了框架和指導。”“我們歡迎 FDA 在確保包括移動醫療應用在內的數字健康產品安全性和有效性的同時鼓勵創新的決定。我們在自然週期的使命是以研究和熱情開創女性健康的先河，這一最後的里程碑標誌著這一旅程的一個非常重要的一步。”
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