What does it mean to be FDA-cleared as a medical device?

The Food and Drug Administration (FDA) is a federal government agency in the United States of America that is responsible for protecting public health and safety by regulating products such as pharmaceutical drugs, biologics, cosmetics and medical devices. Clue Birth Control is designed for contraception, and has been tested in a rigorous clinical trial for that purpose. In order to obtain FDA clearance to develop a medical device, the US regulator examined not just the clinical trial, but subjected the entire app as well as software development processes to extensive scrutiny. We had to prove that our science is sound, and that our way of working is up to the standards expected of a medical device manufacturer. 

 

There are a multitude of period tracking apps on the market that seem to provide fertility predictions but do not provide evidence of how these predictions are made. When people rely on such unregulated apps to prevent pregnancy, they are likely unaware of how big a risk they are taking. The predictive algorithms such apps use may have little basis in science, or the predictions may not be generalizable to a particular type of user, and the apps themselves have probably never been independently audited for quality. Birth control products are highly regulated for a reason; an unintended pregnancy can be devastating, and people have to make careful, informed choices that suit their needs. An app from an unregulated manufacturer should never be relied on for effective birth control.

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