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What You Should Know About the Fertility App that Got Clearance from the Food and Drug Administration

Fertility apps are one of the biggest health trends, especially in Europe and America. These businesses have been growing massively. And while they are heavily criticized by some, more and more women have been adopting these systems.

In fact, during the second half of last year, one of those fertility apps got clearance from the US FDA, the Food and Drug Administration. The app is called Natural Cycles. And the FDA decision has been one of the most polemics and contested to date.

Has the objective judgement of the FDA been blurred by the successful growth of fertility apps? Or do they actually constitute a healthy, safe and efficient option for women?

Natural Cycles

Natural Cycles - What You Should Know About the Fertility App that Got Clearance from the Food and Drug Administration

The Natural Cycles app lets women know when they are fertile based on their body temperature.

It is the first ever contraceptive app to be cleared by the FDA. Many people fear that the decision sets a precedent for multiple undertested apps of the kind to take over the market.

Natural Cycles has not been tested with the same level of scrutiny as the IUD or the contraceptive pill.

In fact, before the app got clearance, several women in Europe had already shared that they got unwanted pregnancies because of the app misreading the data.

Natural Cycles doesn’t require any medical intervention. The only piece of information that the app collects is body temperature.

De Novo Classification

The clearance of Natural Cycles comes in the context of a broader, likely riskier push for more relaxed health standards that has been making the rounds since 1997.

The De Novo process was implemented with the intent of clearing new types of medical devices. Although it has been challenged with opposition and bureaucracy over the past decades, in 2017, the FDA allowed for a less rigorous De Novo classification.

That year, 30 new health devices were cleared by the administration. In 2018, that number was surpassed.

If a health business is growing exponentially in popularity and sales, does it mean it is all set for an FDA clearance? It looks like it.

Investigation

Investigation - What You Should Know About the Fertility App that Got Clearance from the Food and Drug Administration

By the time Natural Cycles got clearance in the USA, the app was being investigated for exaggerating its efficiency. 37 women reported unwanted pregnancies. And that was just in one single Swedish hospital.

The studies that the business published were conducted by the own company, which obviously profits from promoting positive results. So, the accuracy of the conclusions is extremely fragile.

Additionally, several factors besides fertility affect body temperature. They include medication, sickness and drinking habits.

As you can see, there is much involved that makes the clearance of Natural Cycles such a polemic decision from the FDA. The fact is that, efficient or not, the app and others of the type keep growing at a strong pace.

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