Natural Cycles FDA De Novo Record

The FDA’s 2018 De Novo decision names Natural Cycles as a device. This page summarizes that record’s device type and stated indication; it does not provide fertility or contraception guidance.

FDA record fields

The FDA’s De Novo summary includes the classification, device type, and indication. Its De Novo decision record identifies the product and decision.

Compare the exact app and labeling

1. Record the app name, developer, version, and the specific function being described.
2. Match those details to FDA’s De Novo record and product code.
3. Read the indication and labeling for the exact regulatory action.
4. Separate the regulated device function from other app features, interfaces, or data connections.
5. Check current labeling for the app version being reviewed.

For FDA status of an at-home test, see how to check an OTC pregnancy test record. For a regulated postpartum device category, see powered breast pump classification. Browse fertility monitors.

This page describes product labeling and FDA status. Speak with a doctor about reproductive health concerns or medical decisions.

Sources

• Natural Cycles De Novo summary DEN170052, FDA
• Natural Cycles De Novo decision record, FDA
• FDA product code classification database