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When does the FDA consider a component a medical device?

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reginawags

Registered
#1
#1
We produce a staple and load it into a cartridge. It is then sent to our customer for final assembly and packaging. We have been informed by the FDA that the staple as a component is considered a medical device. What is the criteria for considering which type of component is a medical device? I have other parts that we manufacture and I want to be sure we control them properly. Thank you in advance.
 
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shimonv

shimonv

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#2
#2
Below are four important definitions from FDA guidance document entitled: "Medical Device Accessories – Describing Accessories and Classification Pathways".

Accessory: A finished device that is intended to support, supplement, and/or augment the performance of one or more parent devices. Component (21 CFR 820.3(c)): “[A]ny raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.”
Finished Device (21 CFR 820.3(l)): “[A]ny device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.”
Parent Device: A finished device whose performance is supported, supplemented, and/or augmented by one or more accessories.

I hope this can helpful to you.

Shimon
 
R

reginawags

Registered
#3
#3
I have read these definitions as well, what I am trying to understand is - A staple is a medical device component because it is the functioning piece of the final device, but the plastic molded component that holds the staples is not considered a device? It is all pretty confusing.
 
shimonv

shimonv

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#5
#5
I remember way back I used to worked on CT scanners. The Scanner was a medical device by also the X-Ray tube which is a component thereof. It is strange but sometimes a component may raise to a level of a medical device because of safety considerations.
 
I

indubioush

Quite Involved in Discussions
#6
#6
See this: Is The Product A Medical Device?


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:
    1. recognized in the official National Formulary, or the United States Pharmacopoeia, 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 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. The term "device" does not include software functions excluded pursuant to section 520(o).
 
Watchcat

Watchcat

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#8
#8
Your device is not a staple. Staples are sold at office supply stores, and FDA doesn't consider them to be medical devices. If it is a medical device, it is also not a component. You are confusing a contraption with a medical device. There is only one thing that makes something a medical device, and it has nothing to do with its physical design or properties.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#9
#9
shimonv said:
I remember way back I used to worked on CT scanners. The Scanner was a medical device by also the X-Ray tube which is a component thereof. It is strange but sometimes a component may raise to a level of a medical device because of safety considerations.
Click to expand...
X-ray tube assemblies (and other X-ray equipment "components") have a somewhat unique characteristic in that they are sometimes manufactured and sold on their own, to be assembled by X-ray equipment Assemblers (a regulatory-defined entity type) on site, i.e. the Assembler "builds" an X-ray machine on-site from individual modules. So the FDA is trying to ensure that the X-ray tube is safe and effective even before it's integrated in the X-ray machine.

Another unique aspect of X-ray tube assemblies is the applicability of Subchapter J - Radiological Health (21 CFR parts 10xx, especially part 1020.30). Some of the unique requirements actually come from there, rather than from the Medical Devices regulations (parts 8xx).
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#10
#10
reginawags said:
We produce a staple and load it into a cartridge. It is then sent to our customer for final assembly and packaging. We have been informed by the FDA that the staple as a component is considered a medical device. What is the criteria for considering which type of component is a medical device? I have other parts that we manufacture and I want to be sure we control them properly. Thank you in advance.
Click to expand...
I assume you are referring to a surgical staple. If this is the case, the staple is considered a medical device because it can be argued to be intended for one of the purposes listed in the Medical Device definition on its own (after "implantation"). The fact that other elements enable, or assist in, its placement in the body does not change its essence, be these elements consumable components/accessories or reusable apparatuses (e.g. surgical stapler).
 
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