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FDA Clears First App for Contraceptive Use

August 20, 2018

The FDA said it would permit marketing of Nordic AB’s mobile medical application Natural Cycles for use as a method of contraception.

The app received de novo clearance as a stand-alone software application, intended for women 18 years and older, to monitor fertility.

As part of the de novo clearance, the FDA is establishing special controls that clarify expectations in assuring accuracy, reliability and effectiveness. Subsequent devices with the same intended use would go through the FDA’s 510(k) process by demonstrating substantial equivalence.

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