Regulation (CE/FDA)

Updated: June 30, 2020.

The Nori Health program is CE-certified as Class 1 medical device.

Nori Health is currently not regulated by FDA in the United States, based on the (current) intended use of the program and the associated risks involved. You can read more about this below. This page will be updated as we make changes to the content and intended use of the program.

Intended use

Nori is a computer-controlled coach, which is intended for chronically ill patients to improve their quality of life with an adapted lifestyle. This is done in six weeks by informing patients about healthy lifestyle choices, teaching healthy routines and being available 24/7 as a confidential mediator, using scientifically validated questionnaires.

Non-personal and based on scientific research

The messages that Nori currently sends are non-personal and based on existing scientific studies. Included questionnaire is based on IBD CONTROL, a standardized questionnaire used with permission for researching outcomes. The application is a closed system, third parties (including doctors) don’t have access to any patient data.

FDA compliance policy for low risk products

The Food and Drug Administration (FDA) is issuing this guidance document to provide clarity to industry and FDA staff on the Center for Devices and Radiological Health’s (CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general wellness products).

CDRH does not intend to examine low risk general wellness products to determine whether they are devices within the meaning of the FD&C Act or, if they are devices, whether they comply with the premarket review and post-market regulatory requirements for devices under the FD&C Act.

A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

Intended uses to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.

The disease-related general wellness claims should only be based on references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. That is, the claim that the healthy lifestyle choice(s) may play an important role in health outcomes should be generally accepted; such associations are described in peer-reviewed scientific publications or official statements made by healthcare professional organizations.