Advocates for health standards are concerned that Natural Cycles, a smartphone contraceptive app recently cleared by the US, has not been sufficiently scrutinized under Food and Drug Administration Commissioner Scott Gottlieb’s leadership. Its US clearance sets a precedent for more under-tested contraceptive apps to appear on the market, advocates fear.
Natural Cycles determines when users are fertile based on basal body temperature, and is the first contraceptive phone app to be cleared by the FDA. While this clearance may appear to increase the number of effective birth control methods available to patients, it has not been tested with nearly the same rigor as other FDA-approved contraceptives like the IUD or the pill, and therefore...