Is there a counterpart to the General Safety and Performance Regulations for the USA?

[Paul_1993]

Hello,

i was wondering, if there is a counterpart to the GSPR (Annex I MDR 2017/745/EC) or the General Requirements (Annex I MDD 93/42/EEC) in the USA? In Europe there is with Annex I a very detailed list (23 Parts) about the safeness and performance requirements a medical device have to fulfill to get market access.

I would like to compare the list in Europe with the list in the USA if there is one, but I was not able to find it, anybody got a tip for me? Or are the requirements for medical devices only determined via the QSR CFR 820?

I thank you in advance for every clue,

thanks!
Paul

 

[shimonv]

Hi Paul,
In FDA language it is called "General Controls" and "Special Controls". CFR 820 (QSR) is one subset of the General Controls.
Recommended reading:
Regulatory Controls

Cheers,
Shimon

 

[Watchcat]

The EU has always taken a few-sizes-fit-all approach to medical devices. FDA has traditionally followed a model in which each device type is considered individually, thus all the classification regulations and product codes, which determine how each device type is regulated. Under the FDA model, the requirements are either defined by those already associated with a predicate device, or, if your device is novel, you must define them for yourself and then explain them to FDA. In the latter case, they should come out of your risk analysis. IMO.

I don't think FDA's controls are the equivalent of GSPR. FDA's controls are regulatory requirements, not safety and performance requirements. They are what FDA requires you to do in order for it to have confidence that your device will reliably meet its safety and performance requirements. The requirement to submit a 510(k) is a general control. It is neither a safety nor a performance requirement. Its purpose is to give FDA the opportunity to determine whether your device meets safety and performance requirements before it can be legally marketed in the US.

PS "Safety and performance" is the EU term. In the US, it is "safety and effectiveness," although perhaps honored as often in the breach as in the observance. Where the EU's "performance" means technical performance, they are different. Where it means clinical performance, they are at least very similar, and sometimes the same.

 

[D Ray]

The EU has always taken a few-sizes-fit-all approach to medical devices. FDA has traditionally followed a model in which each device type is considered individually, thus all the classification regulations and product codes, which determine how each device type is regulated.

Watchcat (and Paul), you both seem knowledgeable in an area I'm NOT. We hack children's toys from off the shelf and add large EU medical-rated buttons to make them easier for kids to turn on and off. Such as making Micky Mouse dance, or a unicorn whinny and walk, with the push of a 4" button. My question is should we be buying (expensive) medical grade buttons? The toys themselves are not medical grade, so why are we feeling like we need to buy the medical-grade on-off button?

 

[Watchcat]

should we be buying (expensive) medical grade buttons?

The MBA in me says this is a business decision. The logical thinker and communicator in me collaborated and decided that "should" is either referring to one of the Commandments or is meaningless without an "...if we want to..." in there somewhere. In this case, the MBA pops up and says "...if we want to achieve [business objective]." When people use "should," in a forum related to regulated products, usually they meant to say "are required to."

OK, now that I've been annoying enough, I'll answer as if you said "are required to," and leave you to sort out your business objective, which probably has something to do with avoiding regulatory penalties.

With medical devices, regulation and requirements are driven by intended use. If you are not claiming any medical purpose, you don't have a medical device, so neither FDA regulations nor the MDD/MDR apply. That's a problem for you here, because it is medical devices that folks here know a lot about. So unless someone here has knowledge that extends beyond medical devices, we are unlikely to be of that much help.

HOWEVER, before your eyes glaze over at the length of this reply and you give up on us, and especially before you decide whether or not you are claiming a medical purpose, I will advise you that the latter is not for laymen to decide, based on what they think is or is not a medical purpose. That will be defined by the regulators. Sometimes not using that specific term (FDA just babbles about "intended use" and "indication for use") and sometimes not so clearly and sometimes more by deed than by word. So before you abandon your "medical grade" buttons, you might want to spend a little bit of money to have an EU medical device regulatory expert review your claims to confirm that, while you didn't think you were making any medical claims, the regulatory authorities might beg to differ. Again, based on your business objectives, and also your tolerance for regulatory risk.

[If you weren't already using "medical-grade" buttons, I probably wouldn't recommend pursuing the question of whether it is a medical device, based on the information you have provided. However, since you are, and I haven't seen your product literature/advertising, it could mean that somewhere in the prior history of your company, something in your claims led someone familiar with the regulatory definition to think it could be a medical device. Or maybe "medical grade" just sounded good to Marketing.]

If you are not making any medical claims, then my best guess is you are using "medical-grade" (pause while I step outside to shriek "there is no such thing!) buttons to assure biocompatibility and/or electrical safety. Many people in this forum know something about both, but most of us only know something about them as they pertain to medical devices, i.e., devices used for a medical purpose.

On the whole, sounds like this is probably a consumer product/child safety matter, not a medical device matter. You can probably get some help with electrical safety in one of the forums here not dedicated to medical devices. Biocompatibility may be tougher. I understand some testing that might be called "biocompatibility" testing is required for some kinds of products, but I don't know what forum would attract people who are likely to know.

PS In medical devices, there is still a tendency to think narrowly when thinking "biocompatibility," referring only to tests in animals that determine if the device materials are "safe." If a child can swallow the button and choke to death on it, that button is not biocompatible. If the materials prove toxic when ingested (including if just the materials are ingested after a small child sucks on the button...kids, whatcha gonna do), that button is not biocompatible.

PPS I hear the EU is less litigious than the US, but...when I talk about spending a bit of money, I mean, in the US, killing a child with your product can be a very expensive proposition, so worth a bit of investment to assure you are covered if the worst should happen. You absolutely, positively, do not want to kill a child in the US with a product that FDA thinks is a medical device and, because you didn't think it was a medical device, you didn't meet FDA requirements for medical devices, trust me on that. The FDA may be reasonable about it, but the plaintiff's attorney will not. Also well worth an investment to assure that it doesn't kill a child, but that's a separate matter.

Sorry you asked yet?