We are a medical device company that uses CO2 in our process to insuflate a part of the body. The designers of our product have specified the use of medical grade CO2 to accomplish this task. My research of the FDA website says that '...medical grade gas is a drug..'. Does the classification of medical grade gas as a drug have anything to do with the end use of the drug, that is, can we classify it as a component of a finished medical device and thus follow 21CFR820; or is the classification applied at the time of the gas's manufacture and thus the rules of 21CFR210, 211 always apply?

We are a medical device company that uses CO2 in our process to insuflate a part of the body. The designers of our product have specified the use of medical grade CO2 to accomplish this task. My research of the FDA website says that '...medical grade gas is a drug..'. Does the classification of medical grade gas as a drug have anything to do with the end use of the drug, that is, can we classify it as a component of a finished medical device and thus follow 21CFR820; or is the classification applied at the time of the gas's manufacture and thus the rules of 21CFR210, 211 always apply?

Friends,

Any Medical drug/device folks who can help out here?

Stijloor.

I'd think that a pharma-vs-device question would be important enough to your marketing and regulatory stance that you might best get an official statement from the FDA.

You could start out the informal (and free) way by asking DSMICA, and seeing if they're willing to tackle it and if you're willing to bet your marketing clearance on the reference quality of the email you get back. If not, you could file for an official interpretation.

MIREGMGR,

Thanks for the info on DSMICA, I'll give it a try.

Gerry

Hi Gerry,

Yes, medical grade gas is considered a drug.

As per, FRESH AIR 2000 - A LOOK AT FDA'S MEDICAL GAS REQUIREMENTS (http://www.fda.gov/cder/dmpq/freshair.htm) -

Medical gases are prescription drugs that must be dispensed by prescription only. Each firm has a responsibility to determine if its consignee, not the patient is authorized to purchase the drug gas, and if required, is registered with FDA, and properly licensed with the state, where required prior to selling them medical gas.

Also refer this interesting for more info - New regulations on medical gas containers (http://weldingmag.com/gases/news/gwd_18131/)

Ajit,

Thanks for your response and taking the time to help me. That's why I love the cove.

During my research I evaluated FRESH AIR 2000 and FDA Guidance documents. All indicated that Medical Grade Gas is considered to be a drug by the FDA.

It is becoming more apparent that there is no circumstance where a medical grade gas could be considered to be a device.

Gerry

It depends upon the intended use and how/to whom the product is marketed. Some medical gasses/ gas combinations can be medical devices (such as gases used to calibrate medical equipment used in hospitals).

This is one example:

PART 868 -- ANESTHESIOLOGY DEVICES

Subpart G--Miscellaneous Sec. 868.6400 Calibration gas.

(a)Identification. A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 868.9.

[47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001]

geochaz,

Thanks for the reference. Every bit of data helps.

I queried the FDA and got a similar response. In your example and theirs, the gas is being used in a mechanical application. They described a compressed gas being used to power a device and thus the gas was a component of the device. You are suggesting the use of the gas in calibrating other measurement devices.

In both cases the gas is not used in a human.

However, my question does not go the the ultimate use of the gas, but to the creation of the gas. If a gas manufacturer produces a gas (e.g. Carbon Dioxide) and intends for it to be Medical Grade (i.e. it meets the US Pharmacopia description for Medical Grade CO2) then I assume it is a drug. Later it may be used in one of the device applications described above and treated as a device component. But when it is created and called Medical Grade, I believe that it must be treated as a drug.

I also have this passage taken from an FDA guidance Document called:

'Guidance for Industry Current Good Manufacturing Practice for Medical Gases'

Medical gases (e.g., oxygen, carbon dioxide, helium, nitrogen, nitrous oxide, medical air, and 48 combinations of these) are drugs within the meaning of section 201(g)(1) of the Federal Food, 49 Drug, and Cosmetic Act (the Act) (21 U.S.C. 321(g)(1)) and pursuant to section 503(b)(1)(A) of 50 the Act (21 U.S.C. 353(b)(1)(A) are required to be dispensed by prescription.
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03/27/03

Remember, just because an "article" is listed in the USP or NF, does not make it solely a drug. It may be a medical device. The key is how it is used/marketed.

Medical grade means drug/device. However, application wise, certain medical grade gases (i.e. as defined in the USP/NF) should not be used in an industrial purpose. It is not because they are medical, but because their purity specs are lower than the industrial grades. An example is a welding gas... In other cases, the opposite is true.

Here are the section 201 definitions from the Food, Drug & Cosmetic Act. Pay attention to the "and's", "or's, and "not's". They are what diffenciate between a drug and a device.

(g)(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.
(2) The term "counterfeit drug" means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.

(h) The term "device" (except when used in paragraph (n) of this section and in sections 301(i), 403(f), 502(c), and 602(c)) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) 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
(3) 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 its primary intended purposes.