Biocompatibility Testing Requirements for a Class I device - Does not contact patient

I

Illuminatus

#1
Does the FDA require Biocompatibility testing for a Class I device that does not contact the patient?
It might contact something that contacts the patient...

The way I'm reading the FDA G95-1 Memorandum it does not, but I have someone telling me I have to validate biocompatibility to ISO 10993.

Thoughts?
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Re: Biocompatibility Testing Requirements for a Class I device - Does not contact pat

That will depend on the nature of the secondary contact.

A device that is significantly handled by a surgeon who then directly puts his/her hand into a patient incision is (in my view) creating significant indirect patient contact.

A device that is incidentally and briefly touched by a nurse or technician who at some later time might incidentally and briefly touch the patient's intact skin, is (in my view) not creating significant indirect patient contact.

In between the examples is, of course, a gray area.

If your situation isn't clear enough for your company to make a judgement call that it'll be comfortable defending, you may have to contact FDA and get them to make a judgement call for you. That can be easy if you're lucky and talk to the right person on the right day, or it can involve a formal filing and a formal ruling. You could start by calling DSMICA and seeing if they'll point you to someone that'll help you the easy way.
 
A

Adele

#3
Re: Biocompatibility Testing Requirements for a Class I device - Does not contact pat

First of all, the classification of a device shouldn't really come into your assessment of whether you need biocompatibility testing.

IMO you should make an assessment as to whether there is contact and document your decision accordingly - as MIREGMGR says,it depends on the nature of the secondary contact. You may want someone more experienced and independent to review and sign your assessment.

The FDA is becoming more open to the idea of risk management principles for biocompatibility.
 

Ronen E

Problem Solver
Moderator
#4
Re: Biocompatibility Testing Requirements for a Class I device - Does not contact pat

First of all, the classification of a device shouldn't really come into your assessment of whether you need biocompatibility testing.
The FDA is becoming more open to the idea of risk management principles for biocompatibility.
To me this a bit of a contradiction - classes are based on risk level, and so if the FDA is becoming more open to risk management of X aspect, I would expect that the device's class would be of some relevance :)

That aside, class I devices are only subject to the FDA's general controls, which are (refer http://www.fda.gov/MedicalDevices/D...verview/GeneralandSpecialControls/default.htm):

1. Establishment Registration
2. Medical Device Listing
3. QSR (21 CFR Part 820)
4. Labeling regulations
5. Premarket notification [510(k)]

Out of these, only #5 specifically poses biocompatibility testing requirements; however, most class I devices are exempt from 510(k) submission. The fact that a certain device type is classified under class I, and that that specific type is/isn't exempt from 510(k) submission is (in my perception) not without a reason.

I do agree though that if the specific case raises significant concerns it would be advisable to contact the FDA with that query, or at least be prepared with a good defence case.
 
M

MIREGMGR

#5
Re: Biocompatibility Testing Requirements for a Class I device - Does not contact pat

class I devices are only subject to the FDA's general controls
at least be prepared with a good defence case
The weakness of the first quote above as a basis for the second quote above is that FDA has considerable flexibility to overrule your analysis of your product's best classification because of the legacy complications of the ProCode system, and has exhibited a willingness to do so when they think your classification choice doesn't accomplish sufficient safety and effectiveness.

Note that, as an example, manual surgical instruments--scalpels and knives--are generally classified as US FDA Class I. See for instance ProCodes GES, KAS, HNN, KBQ. I don't think anyone would argue that there's no need to assure patient-contact biocompatibility for such devices. If an adverse event involving biocompatibility of such a device were to occur, or if design of such a device were reviewed as part of an inspection, I doubt if the FDA would regard such biocompatibility as not having been required.

As another example, a sterile-barrier equipment cover for a non-electric opthalmic surgical microscope may be correctly classified as Class I, ProCode HRB or as Class II, ProCode HMW. Historically, the same product was submitted for initial classification by two separate makers at separate times; FDA internally assigned the product on the two occasions to different medical-specialty review committees (of which they have 19); and conflicting results occurred. There are many other such boundary conflicts.

While it often is said that the FDA's classes are risk based, historically this has not consistently been the case. At least in my view, for legacy reasons the FDA's classifications and product code assignments are quite inconsistent and not objectively related to any single rule-basis, and cannot be solely relied upon as a risk guide if the device maker's regulatory approach is either "do the right thing" or avoidance of FDA second-guessing in the event of a problem.
 

Ronen E

Problem Solver
Moderator
#6
Re: Biocompatibility Testing Requirements for a Class I device - Does not contact pat

FDA has considerable flexibility to overrule your analysis of your product's best classification... and has exhibited a willingness to do so when they think your classification choice doesn't accomplish sufficient safety and effectiveness.
True. I related to the class I classification as already-substantiated, not as a hypothesis. Clearly if the device is eventually classified higher, the case I presented becomes irrelevant.

Note that, as an example, manual surgical instruments--scalpels and knives--are generally classified as US FDA Class I. See for instance ProCodes GES, KAS, HNN, KBQ. I don't think anyone would argue that there's no need to assure patient-contact biocompatibility for such devices. If an adverse event involving biocompatibility of such a device were to occur, or if design of such a device were reviewed as part of an inspection, I doubt if the FDA would regard such biocompatibility as not having been required.
Again, true. I didn't say biocompatibility in whole is not applicable to class I. I merely pointed out that except the 510(k) control (which is not applicable to many class I devices), general controls do not pose specific biocompatibility testing requirements. Biocompatibility can be addressed in other ways, such as using materials and processes that are known to be fit-for-purpose (in that regard); especially in applications with extensive field experience and associated knowledge base, such as surgical blades. I assume these characteristics played a role in the process which classified such devices under class I in the first place. Otherwise, I fail to understand the logic behind the apparent applicability of 3 different control levels (classes) whilst at the same time extra requirements are posed de-facto, be it for whatever reasons. Call it legacy complications if you wish, I call it lack of transparency.

As another example, a sterile-barrier equipment cover for a non-electric opthalmic surgical microscope may be correctly classified as Class I, ProCode HRB or as Class II, ProCode HMW. Historically, the same product was submitted for initial classification by two separate makers at separate times; FDA internally assigned the product on the two occasions to different medical-specialty review committees (of which they have 19); and conflicting results occurred. There are many other such boundary conflicts.
OK, so the decent thing would be to call it what it actually is - a mistake; and make amends based on reason and the law. Not to make such cases a basis for grey-ness wherever reviewers / investigators find it convenient. If a device is truly deemed to require full-blown special controls (or just the full set of general controls, including 510(k) submission) - so be it!... But if it's actually of low risk, why burden industry beyond necessity?

While it often is said that the FDA's classes are risk based, historically this has not consistently been the case. At least in my view, for legacy reasons the FDA's classifications and product code assignments are quite inconsistent and not objectively related to any single rule-basis, and cannot be solely relied upon as a risk guide if the device maker's regulatory approach is either "do the right thing" or avoidance of FDA second-guessing in the event of a problem.
Doing the right thing is not limited to FDA's spelled out requirements. I believe manufacturers should do whatever is necessary for establishing - first of all - their own confidence in their own devices, regardless of FDA's requirements / expectations. At the same time, why wouldn't they benefit any exemption / concession orderly granted by the FDA? I know, we can't rely on manufacturers to safeguard public health etc. etc.; in that context - if you believe certain product codes and their associated controls compromise public safety, isn't there a way to promote upclassification?
 
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M

MIREGMGR

#7
Re: Biocompatibility Testing Requirements for a Class I device - Does not contact pat

I wasn't disagreeing with your earlier post. I was only providing additional information for the OP. I would agree with most of your views, but of course neither of us is in a position to fix what could stand fixing at FDA.
 
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