FDA Factsheet
1. What is the FDA and what does it do?
The FDA (The Food and Drug Administration) is a federal agency in the U.S. that is responsible for protectingand promoting public health. The FDA regulates a wide range of products, including foods, human drugs andmedical devices.1

2. The Natural Cycles app is cleared as a Class II medical device
by the FDA. What does this mean?
The FDA has a risk-based classification system where medical devices are assigned to one of the three regulatoryclasses: Class I, II, or III.1 The Natural Cycles app has been classified as a Class II device.2
Being FDA cleared means that the Natural Cycles is a legitimate medical device for use as a method of birthcontrol in the U.S., under the regulation of the FDA.2

3. Which regulatory pathway did Natural Cycles go through?
For new medical devices in Class II, there are two regulatory pathways to secure
clearance – the 510(k) and De Novo pathways.
510(k)De Novo pathway

510(k) is the most common regulatory pathway, where
manufacturers provide data to demonstrate that theirproduct is substantially equivalent to an existing legallymarketed device (predicate device).

De Novo pathway, on the other hand, is for new, novel
medical devices for which there is no valid predicate
device – i.e. there is nothing comparable in existence.

Initially, Natural Cycles filed a 510(k) application, but the filing was escalated tothe de novo pathway since there was no legally marketed device similar to theNatural Cycles app. In August 2018, Natural Cycles became the first app of its kind
to be cleared by the FDA as a method of birth control, setting the framework andguidance for future clearances of a similar nature.3

Regulatory Journey
2017

2018

JunAug

SepDecNatural Cycles
Nordic AB filed a510(k) request tothe FDA

The FDA
determinedthat the NaturalCycles app was
not substantiallyequivalent to any
legally marketed
device and therefore
recommended
the De Novo
classification route

Natural Cycles
submitted the De
Novo request

The FDA reviewed
the evidence
NC provided
and requested
additionalinformation

Mar

Jul – AugAug

The FDA and Natural Cycles
had a Q&A meeting inWashington D.C.
for further clarification

Period of bilateral scientificand regulatory review

The FDA granted theDe Novo request classifying
the Natural Cycles
app as a Class II
medical device

4. What clinical data did the FDA examine?
The FDA evaluated results from three clinical studies,4,5,6 which included more than 22,000 women; following thisreview, it requested an additional analysis to isolate data from women who were using the app with the most recent
algorithm version (version 3).2 This prospective analysis involved 15,570 women, who used the app for an averageof eight months.2
Based on its analysis of these data, the FDA cleared Natural Cycles as a Class II medical device for use as amethod of birth control.3

5. What other data did the FDA examine?
Beyond clinical information, Natural Cycles provided detailed
software-related documentation.
The documentation described:
Design of the software
Implementation of the design
Software testing process
Identification and managementof hazards and risks

Traceability steps
Handling and protection of personal
data in accordance with regulations
and standards

According to the FDA, the documentation provided sufficient evidence of safe andeffective software performance.2