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About Medical Purpose Claims

Thanks for your helpful device series. My question is a device- esp. class I- is one that intended for a "medical purpose"- has FDA clarified what kinds of claims are "medical purpose" claims?



This is an interesting question. Let's try to unravel the meaning of "medical purpose" together. 

The FDA uses the term "medical purpose" in a variety of guidance documents. Let us examine two excerpted quotes from FDA documents and one from a sister agency CMS (Centers for Medicare and Medicaid Services). 

1. "As described in 21 CFR 878.9, exemption of class I devices does not apply where: 1) the device is intended for a different use, e.g., a different medical purpose; or 2) the device operates using a different fundamental scientific technology." 

Here, as you can see, the term "medical purpose" is used as an example of a "medical use".

2. "Accordingly, a class II device listed in this document is not exempt if such device: (1) has an intended use that is different from the intended use of a legally marketed device in that generic type; e.g., the device is intended for a different medical purpose, or the device is intended for lay use instead of use by health care professionals; or (2) operates using a different fundamental scientific technology than that used by a legally marketed device in that generic type;"

Here, the term "medical purpose" means its "intended use".

3. "DME is medical equipment DME is medical equipment which is which is primarily and customarily used for primarily and customarily used for medical purposes and is not generally medical purposes and is not generally useful in the absence of illness or useful in the absence of illness or injury. 

"This quote is referring to Durable Medical Equipment, such as wheelchairs. It adds the useful explanation that such a device would not generally be useful "in the absence of illness or injury". This brings us to the definition of "medical device".

A medical device is a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act."

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 any of it's 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." 

I would conclude that a "medical purpose" means that the intended use is in accordance with the definition of medical devices.

About Registration for Cosmetic Dentistry Products

We are a company located in Millbrae, California, specialized in the products for cosmetic dentistry. We have contracted two products for manufacturing in China: plasmas arc dental curing light and LED dental curing light. In order to bring in the products for our distribution in the US Do we as an American company have to register the two products?

The products, I believe, are classified as ultraviolet activators for polymerization. These are Class 2 medical devices and require premarket notification (510(k)) clearance before they can be marketed in the U.S. The Manufacturer in China is required to have a single U.S. Agent to facilitate communications with the FDA. In addition the Manufacturer must register his facility and submit device listing forms to the FDA. Finally, and most important, the manufacturer must meet the U.S. Quality Systems regulation. 

Your company must also register with the FDA and submit a device listing form. You do not need a U.S. agent. You also must meet certain requirements of the Quality Systems regulation. It is up to you and the manufacturer who will be the sponsor of the 510(k)).

For your information, Estrin Consulting Group, Inc. can act as the U.S. agent for the manufacturer and also assume responsibilities as "Official Correspondent", which involves submitting the device listing forms and annual manufacturer registrations. We also prepare 510(k) submissions and can assist you and the manufacturer in China in meeting the FDA's Quality Systems regulation.Please contact me if you still have questions. For more information about my company, see the website below. Let me know how I can help you.

About Validation

I being working for a company for a few years as production supervisor, we re-pack just class I devices, by my boss instructions, we send just one product of 25 products, every three months for the sterilization audit, we never send the other products to the Lab, when I asked, he told me the we just need to validate the worse product and it will cover the other products, is this correct? Thank you very much for your time.

Thank you for your question. It is a good one. Your company needs to validate that the process controls, such as temperature, humidity and time will result in sterilization of your product. Your company has to determine how many samples will give that assurance. There is no magic number.


Many companies follow consensus standards. (For example, AAMI, ANSI or ISO standards). I have attached an FDA presentation of validation to help you understand the process.  Also, for a thorough understanding of the FDA's Quality Systems Regulation, see 


Regarding Sterilization......... Dr Norman Estrin further advised as follows ; 


I contacted a sterilization expert. 


This is what she said: "First of all, is this gamma sterilization? If so, it is OK to select a master challenge product to represent all the products. The selection must be documented and the rationale for the selection outlined. But they are wrong about the quarterly audit. Usually 100 units are dosed at verification dose, followed by sterility testing. There are some other dosing regimens, but I'd have to know more...and this would result in something called "consulting". 


I hope this helps. 


If you have additional questions, please let me know. 

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