California Prop 65 requirements as they relate to 820.120

jozy80

Registered
Just to be clear, my understanding is pretty much based on reading the code and other people's opinions on the internet :) but I'll give you my opinion anyway...

The short answer: putting a label on the product is not that difficult, doesn't require your customer to do any work, fully covers you from a regulatory perspective, and it's easily ignored (in this case, that's a good thing). What is the benefit of doing something different?


1) If your device exposes patients or any other people to a material, it is not an "occupational" exposure because they aren't employees. The code specifies that if an exposure is not a consumer product exposure or occupational, it is environmental, which requires either a sign to be posted, or notification to be provided to anyone in the affected area (every 3 months, not annually).

In reality a lot of purchasers (at least for larger healthcare orgs) will have a list of requirements that they check for during procurement so if they are in California they may ask about Prop 65 labeling at that point. It may be a no-go if you don't have a label and you inform the customer that they have to put up a sign or ship out a notice or something.

From a sales perspective... You are also then competing against other products that don't require additional work and aren't obviously "hazardous". Imagine the headache for a hospital of sending out a mass mailing or printing out and getting people to sign a form that warns them they could get cancer from one device. That's actual time and expense that you are forcing them to spend to use your product, when they probably have other options that don't require any work. My sales team would have a fit if I told them that was required to sell in CA!

2) For a consumer product an eIFU would not suffice based on the requirements for the warning:
View attachment 30621

The reason mfgs. are risk averse about Prop 65 is that this isn't an argument you have with a regulator during an audit.... it is an argument you have to pay a lawyer to make for you in court. The penalties are something like $2500/day for not complying. Given the potential $$$$$$ of getting caught for not complying, it's just easier to do it.
very helpful, thank you!

My current understanding is that many medical devices are typically technically "environmental exposures". This would require as you say a sign with 72 size font, make everyone in the area aware, etc etc. Clearly most medical device companies do not do this. Does this mean they just blanketly follow the "Consumer product" requirement (even though many devices dont fall into this defintinion)
 
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