Is Natural Cycles FDA approved?

Natural Cycle mention in "Is Natural Cycles FDA approved?" questionNo, Natural Cycles has not yet been "approved" by the FDA. However, Natural Cycles was "cleared" by the FDA in 2018 and has the unique distinction of being the first ever birth control app to be cleared by the Food and Drug Administration. You might be asking: what is the difference between being approved and being cleared by the FDA? When the FDA approves something, they've determined that "the benefits of the product outweigh the known risks for the intended use" of that product. However, when the FDA has cleared a product, this means that the manufacturer of the product (in this case, Natural Cycles) was able to successfully demonstrate that their product was "substantially equivalent to another (similarly) legally marketed device" that has already been approved by the Food and Drug Administration.

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Natural Cycle

Natural Cycle

FDA approved digital contraception with 98% effectiveness

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