CDRH Classifies Software App for Contraception into Class II

Regulatory NewsRegulatory News | 05 March 2019 |  By 

Following the 2018 US Food and Drug Administration (FDA) approval of the country’s first mobile medical application indicated for contraceptive use, the agency issued a final order Tuesday to classify the software app for contraception as a class II device.

The regulation set forth in the final order comes as a result of the 2017 de novo classification request FDA’s Center for Devices and Radiological Health (CDRH) granted to Swedish startup company Natural Cycles Nordic AB last August for its Natural Cycles app. The classification into class II has been applicable since then, but the final order establishes the required special controls and codifies the new regulation.

Classification orders are intended to reduce regulatory burden and increase patient and health care provider access to devices by enabling industry use of the less burdensome 510(k) clearance pathway.  

CDRH determined the special controls will provide a reasonable assurance of safety and effectiveness based on its review of Natural Cycles’ de novo request. A software app for contraception must comply with the special controls identified in the final order to fall within the new regulation and thus avoid being automatically classified into class III. A set of four mitigation measures set in the regulation are intended to address the identified risk of unintended pregnancy. These relate to app software verification, validation and hazard analysis, clinical performance testing, human factors and usability testing, as well as labeling.

The August 2018 order to Natural Cycles allowed for the company’s contraceptive app to be used as a predicate device for future devices of the same type. The de novo request was granted, however, amid regulatory investigations against Natural Cycles’ app in the EU over reports of unplanned pregnancies.

Final order


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