Veterinary device is medical device or not?

luloo117117 · Dec 31, 2008

Veterinary device is medical device or not? According to the following FDA's definition, veterinary device is medical device, but why people always call device used not for human is not medical device? Confused.

Based on FDA's memo:

http://www.fda.gov/cvm/regofdevices.htm

May 2003
The Federal Food, Drug, and Cosmetic Act (the Act) defines medical devices as "an instrument, apparatus, implement, machine, contrivance, implant, in-vitro reagent, or other similar or related article, including any component, part, or accessory thereof, which is intended for use in the diagnosis of disease or other conditions; in the cure, mitigation, treatment, or prevention of disease in man or other animals; or which is intended to affect the structure or any function of the body of man or other animals." Further, a device "does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals, and is not dependent upon being metabolized for the achievement of any of its principal intended purposes." Examples of devices include such things as needles, syringes, surgical instruments, prosthetic devices, X-ray equipment, certain diagnostic test kits, and dental appliances.

---FDA

MIREGMGR · Dec 31, 2008

luloo117117 said:
(...)why people always call device used not for human is not medical device?

Within the US marketplace, such descriptions are erroneous.

Ajit Basrur · Jan 4, 2009

As long as the veterinary device fits the definition,

A device is:

"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."

Btw, do you have any specific veterinary device in mind that needs to be resolved ?

howste · Jan 4, 2009

luloo117117 said:
Veterinary device is medical device or not? According to the following FDA's definition, veterinary device is medical device, but why people always call device used not for human is not medical device?

Here's the definition developed by the Global Harmonization Task Force (GHTF)(also contained in ISO 13485):

N029R11 said:
3.7 medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
- investigation, replacement, modification, or support of the anatomy or of a physiological process,
- supporting or sustaining life,
- control of conception,
- disinfection of medical devices,
- providing information for medical purposes by means of in vitro examination of specimens derived from the human body,
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

My emphasis in blue...

howste · Jan 4, 2009

Oh, here's a link to the updated GHTF document dated May 20, 2005: http://www.ghtf.org/documents/sg1/sg1n29r162005.pdf

The definition hasn't changed in the newer version. Look at note 2 for clarification(?) of devices used for animals:

N29R16 said:
Note 2: Products which may be considered to be medical devices in some jurisdictions but for which there is not yet a harmonized approach, are:
· aids for disabled/handicapped people,
· devices for the treatment/diagnosis of diseases and injuries in animals,
· accessories for medical devices (see Note 3),
· disinfection substances,
· devices incorporating animal and human tissues which may meet the requirements of the above definition but are subject to different controls.

(My emphasis in blue again)

luloo117117 · Jan 6, 2009

If veterinary device is medical device, should its manufacturer always complies ISO 13485 or QSR?

MIREGMGR · Jan 6, 2009

The FDA of course regulates the US marketplace.

From http://www.fda.gov/cvm/regofdevices.htm:

Pre-market Approval is Not Required:

The FDA does not require submission of a 510(k) or formal pre-market approval for devices used in veterinary medicine. Firms that manufacture radiation emitting devices need to register their products under the radiological health regulations, administered by the Center for Devices Radiological Health (CDRH).

Device manufacturers who exclusively manufacture, or distribute veterinary devices are not required to register their establishments and list veterinary devices.

FDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded, mislabeled or adulterated.

It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices are safe, effective, and properly labeled.

FDA recommends that devices should meet or be equivalent to the (human-use-device added by MIREGMGR, this is a correction of an FDA website typo) performance standards. This is especially important (for another website typo correction) devices that can be used both in humans and animals, such as examination gloves, sterile catheters, infusion pumps, etc.

FDA recommends that manufacturers and/or distributors of veterinary medical devices request a review of their product labeling and promotional literature to ensure that it complies with labeling and regulations. This includes devices marketed in another country and offered for importation into the U.S.

Ajit Basrur · Jan 7, 2009

luloo117117 said:
If veterinary device is medical device, should its manufacturer always complies ISO 13485 or QSR?

If the device is for US market, QSR compliance is urged but for the rest of the world, ISO 13485 is recommended.

This is because QSR is line with ISO 13485:2003 version. Since FDA regulates the US market, compliance to QSR is to demonstrated.

Btw, you havent answered my initial question as to what is this veterinary device that is being discussed here ?

luloo117117 · Jan 7, 2009

The veterinary device I am asking here is Surgical Laser (for horse, dog and cat, etc.) and Therapy Laser ( for horse, dogy and cat, etc.). We submit annual report to CDRH because it is Radiation Device. Our company manufactures other medical devices for human use and got ISO 13485: 2003 under CMDCAS already, but we declaim the scope of our Quality System complied with QSR, ISO 13485 and CMDCAS is ONLY medical device. So it's why I ask if veterinary device is medical device or not. We do not want to do the same work for animal device as we do for human used device.

luloo117117 · Jan 9, 2009

What is this veterinary device that is being discussed here is a veterinary therapy laser.

Veterinary device is medical device or not?

luloo117117

MIREGMGR

Ajit Basrur

howste

Thaumaturge

howste

Thaumaturge

luloo117117

MIREGMGR

Ajit Basrur

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