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Biocompatbility testing on Class 1 device requirements

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shimonv

Trusted Information Resource
#2
Not true. As long as it comes in contact with human skin/tissue and is being used for a medical application - it requires biocompatibility testing, unless you can provide a very good rationale it is not required.
 

planB

Super Moderator
#3
Concurring with shimov: body-contacting medical devices require a biocompatibility evaluation demonstrating that the device does not cause an inacceptable biological response. In case you have enough data at hand to show that, you may omit testing. Otherwise, you will have to close these data gaps by testing.

Hope this helps,
 
#4
Thank you for your input, but Is there an FDA document that clearly states theat being 510(k) exempt does not exempt the manufacturer from biocomp testing?
 

Janie

Registered
#6
Yes, but in the Introduction to that document, it states that the guidance is to assist in preparing premarket applicatons HDEs, IDEs, 510ks, and De Novo request. The trach tube holder is exempt.
 

shimonv

Trusted Information Resource
#7
Janie,
I looked in the 2003 and 2018 edition of ISO 10993-1 and there is no mentioning of premarket application.
Either way, you are expert from it, but not from applicable standards.
 

planB

Super Moderator
#8
Janie,

have a look into FDA's guidance on biocompatibility section II, Scope:
The scope of this document and accompanying attachments is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body.
Has your device body contact?

If yes, just because your device is exempt from pre-market approval, does not imply that you are exempt from demonstrating documented biocompatibility for your body-contacting device according to its defined intended use.

If no, well then the topic of biocompatbility does not affect your device.

Hope this help,
 

Watchcat

Trusted Information Resource
#10
Is a tracheostomy tube holder exempt from biocompatiblity testing requirements simply because it does not require a 510(k)?
IMO, Exemption from the requirement to submit a 510(k) notification to FDA is limited to just that. You don't have to submit a notification to FDA. It doesn't exempt you from anything else, including, IMO, the need to have data showing substantial equivalence to another legally marketed device that is exempt from the requirement to submit a 510(k) notification to FDA. I don't think it is a device that is exempt from anything just because you say so. It has to be SE to another device that is exempt from 510(k) notification, or it has to have been classified as 510(k) exempt device via De novo.

Regardless, like all medical devices regulated by FDA, it is subject to general controls. IMO, if it is dangerous to health, it is misbranded, and, if you haven't established biocompatibility, you don't know if it is dangerous to health, so a claim that it is safe for its intended use is false and misleading.
General Controls for Medical Devices

I repeat IMO a lot here because I'm not sure even FDA knows what it thinks about all of this. I don't know that it's had enough exposure to devices claiming to be 510(k) exempt to have even developed an opinion. Especially an informed opinion. What I'm pretty sure of? If a device the manufacturer claims is 510(k) exempt causes problems due to a lack of biocompatibility, and the manufacturer never evaluated it for biocompatibility, FDA will quickly develop a very strong opinion about that particular device and manufacturer.
 
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