When does the FDA consider a component a medical device?

#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.
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#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
 
#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

Trusted Information Resource
#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.
 

indubioush

Quite Involved in Discussions
#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

Trusted Information Resource
#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

Problem Solver
Staff member
Moderator
#9
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.
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

Problem Solver
Staff member
Moderator
#10
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.
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).
 
Thread starter Similar threads Forum Replies Date
T Does FDA consider Flow Charts sufficient instruction for SOPs? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
William55401 How Often Does FDA State Consultant Recommended in a Pharma WL? US Food and Drug Administration (FDA) 1
M Does cFDA accepts FDA approval or CE marking? China Medical Device Regulations 1
P Warning Letter 1999 - Where does the FDA make older warning letters available? US Food and Drug Administration (FDA) 4
supadrai How does the FDA count violations of, for example, misbranding? (Medical Devices) Other US Medical Device Regulations 1
K Where does the FDA post its various compliance dates? US Food and Drug Administration (FDA) 2
R FDA 510K - Does the FDA accept the testing report from other countries? Other US Medical Device Regulations 1
N Does FDA allow comparing with the competitors Medical Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
I 510k Performance Testing Studies (Raw Data) - What does the FDA expect 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Q When does the FDA deem something "where appropriate"? 21CFR820.30(g) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
M FDA 21 CFR 820.250 - Does "valid statistical" always mean math? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
B How does a Kit Assembler proceed after FDA Establishment Registration? Other US Medical Device Regulations 3
R Does FDA allow e-labeling? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S Does FDA expect suppliers to be independently assessed to 21 CFR Part 820 ? US Food and Drug Administration (FDA) 4
Y FDA - Does anyone have conduct the validation on GR&R worksheet before? Qualification and Validation (including 21 CFR Part 11) 7
K What liability does the QA Manager/Management Rep hold? (US FDA environment) Career and Occupation Discussions 4
AnaMariaVR2 St. Jude Medical does the unthinkable: Warns of FDA warning letter before FDA issues US Food and Drug Administration (FDA) 5
R Does FDA require monitoring competitor device failures for preventive action? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Does any one have FDA 21 CFR Part 820 QSR training material? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
B Does a US FDA Class I (exempt) device require a Statement of Intended Use? Other US Medical Device Regulations 3
D Will buyers (hospitals) require IEC 60601, even when FDA does not? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
C Does FDA cGMP apply to Laboratory Equipment? ISO 13485:2016 - Medical Device Quality Management Systems 2
C Medical Device Malfunction during misuse - Does this need to be reported to the FDA? Other US Medical Device Regulations 5
D DHF Review - When does the FDA review the DHF? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
D Does Canada have an equivalent to FDA preIDE meeting? Canada Medical Device Regulations 4
A How long does it take US FDA to issue a Warning Letter Close Out Letter Other US Medical Device Regulations 2
R First MDR (Medical Device Report) - Does the FDA give feedback? US Food and Drug Administration (FDA) 4
Y Does FDA have regulations about Braille use for Medical Device Other US Medical Device Regulations 2
E Does the US FDA issue GMP certificates? Other US Medical Device Regulations 2
M Does a dental handpiece need FDA permission? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Q FDA Inspector - What does it take to become an FDA inspector? US Food and Drug Administration (FDA) 4
E Does European Manufacturer with ISO 13485 need QSR820 for FDA registration? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
C Does FDA change the information about" wire transfer" US Food and Drug Administration (FDA) 1
S Does anyone know if ISO publishes audit findings/results much like the FDA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
M Does FDA allow you to withdraw a CAR once it is in your system Nonconformance and Corrective Action 3
I 510k Approval - Does the FDA look for Clinical Data 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
S How often does the FDA inspect organisations outside of the USA? US Food and Drug Administration (FDA) 12
T Submission of 510(k) - Does the FDA require a predefined structure of the content? ISO 13485:2016 - Medical Device Quality Management Systems 2
S FDA Validation - Does one have to conduct validation for Computer Servers? Qualification and Validation (including 21 CFR Part 11) 8
G Does The FDA oppose the use of Process Flow Charts? ISO 13485:2016 - Medical Device Quality Management Systems 8
P How does the FDA's SMG 2020 compare to ISO/TR 10013:2001? US Food and Drug Administration (FDA) 2
R Does anyone have any information on FDA's SMG 2020 issued Oct 04. US Food and Drug Administration (FDA) 1
L CE Mark - FDA - Class I traction systems - What is involved and how long does it take EU Medical Device Regulations 5
Q FDA Establishment Registration - Does registration require compliance to the QSR? ISO 13485:2016 - Medical Device Quality Management Systems 8
A What does the FDA think about 13485? Will the FDA upgrade 21 CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
J Does Pakistan Medical Device Import License allows parallel import? Other Medical Device Regulations World-Wide 0
Similar threads


















































Top Bottom