NEW FROM FDA!
General Wellness: Policy for Low Risk Devices Guidance for Industry
and Food and Drug Administration Staff Contains Nonbinding
Recommendations Table of Contents
I. Introduction 1
II. Policy on Low Risk General Wellness
III. General Wellness Products
IV. Determining Risk for General Wellness Products
V. Examples of General Wellness Products that Are Not Medical
Devices and Examples of General Wellness Products that Are Medical
Devices for which FDA Does Not Intend to Enforce Requirements
VI. Determining whether General Wellness Products are within
Scope of the Guidance
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).1 This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products.2
Neurofeedback professionals are the ultimate link between neuroscience and applied science.
Their knowledge of how different brainwave patterns are closely linked to individual physical and mental states is unprecedentedly, something that will change the world most in the years to come.
Antidepressants are a subject that is more and more on the horizon of criticism and doubts, and they will get more alternatives sooner than later.
One of them recently is cannabis and CBD oils, now Bellabee, closely partnering with NFB experts.
BELLABEE COMBINES THE SCIENTIFIC KNOWLEDGE OF NEUROLOGY
WITH MODERN TECHNOLOGIES, USING THE NERVOUS SYSTEM TO CHANGE MEDICINE.
When it comes to research studies and using knowledge to build a product, it DOES NOT GET ANY BETTER THAN NASA AND CLINICAL TESTS PUBLISHED ON SCIENCE DIRECT, PUBMED AND NATIONAL CENTER FOR BIOTECHNOLOGY INFORMATION of more than 10,000 research papers and 2000 plus double blind studies on PEMF therapy.