AA or AAA batteries a medical device?

S

Silvertabb

AA or AAA batteries used to provide power to medical devices are considered medical devices (accessory) if they are provided by the device manufacturer to the end user? If yes, what is the minimum regulatory requirements the manufacturer has to fulfill?
 

somashekar

Leader
Admin
AA or AAA batteries used to provide power to medical devices are considered medical devices (accessory) if they are provided by the device manufacturer to the end user? If yes, what is the minimum regulatory requirements the manufacturer has to fulfill?
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.


Per the above definition of Medical device in ISO13485, an AA or AAA battery would not be classified as a medical device. My take again is that even under the US FDA definitions, this battery would not be classified as a medical device. Please check on this.
Normally, the manufacturer provides or mentions in the instruction what makes / types of batteries are recommended for use.
 
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M

MIREGMGR

I gather from the wording of the question that you are inquiring about the MDD definition.

From MDD:

[FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]accessory[FONT=TimesNewRoman+20][FONT=TimesNewRoman+20][/FONT][/FONT]means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
My interpretation of the above is that an article which is of a generic design and purpose and was not designed by the article manufacturer specifically to be used with a particular medical device, is not an accessory.
 
M

MIREGMGR

US FDA's 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."
My interpretation is that a generic battery, not specifically intended by its manufacturer for use in a medical device, is not a medical device.
 
S

Silvertabb

What if the manufacturer stock these batteries in its inventory system and provide them to customers when they ask for them? These batteries when bought already come packaged and labeled. If the batteries are sent to end users through the medical device manufacturer inventory system, what labeling requirements need to be fulfilled by the manufacturer? Does the manfacturer have to include its name and some tracking number on the package they send to the end users? If there is no legal agreement between the general use batteries, can the device list itself as a distributor?
 
A

amitkbme

In my opinion, the AA, AAA battery are a universally available battery. Specially not manufactured by that manufacturer or OEM for a particular device. And according to the FDA and EU directives, it can not be a component. If the battery is other than AA, AAA and manufactured by itself for specific device, it would be a component.
 
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