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?