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FDA (U.S. Food and Drug Administration) and PEMF

United States Food and Drug Administration regulations as they may relate to PEMF devices and companies. (read more about animal devices below)

The FDA regulates both human medical devices as well as animal and veterinary products, which is why it is so important to stay up to date on their policies.  The AOPP continues to monitor the FDA for any major news regarding the PEMF industry at large.  Here, you can read a little more about how the FDA regulates both animal and human products, and places to search for a manufacturer or product to check its FDA status.

Products and industries the FDA regulates:

Food, drugs, medical devices, radiation-emitting products, vaccines, animal and veterinary products, cosmetics, and tobacco products.

Relevant articles from the FDA website with links

Medical Device Overview

What is a medical device?

The FDA defines a medical device as:

    • “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

Medical device classification

Currently medical devices fall into one of three medical device classifications: Class I, Class II, and Class III.  Class I includes devices with the lowest risk and Class III includes those with the greatest risk.

Link to FDA page regarding medical devices for humans: FDA: what is the definition of a medical device?

Search the FDA database for a product or manufacturer: search FDA medical device database


How the FDA regulates animal devices

This article, directly from the FDA website, explicitly states that they do regulate animal devices, although they do not require pre-market approval, they also maintain independent discretion as to regulatory action against “bad actors”.

Read the full article: https://www.fda.gov/animal-veterinary/animal-health-literacy/how-fda-regulates-animal-devices


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