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Need clarification on requirements.... Class i, gmp & 510(k) exempt

qu1nn

Involved In Discussions
#1
I work for a company that manufactures Class I weigh scales sold in the United States.
Several of the scales fall under product code INF (link)
The product is listed as GMP exempt, 510(k) Exempt.
The product may be battery powered or wall powered.
Where in the regulations does it state or imply that you would have to perform 60601 types of safety testing? (Is it solely based on the determination of risk and risk deemed acceptable by the company.... But it's design control exempt too... Right??)


Thanks for your time

Qu1nn
 
#2
GMP is the old regulation that was replaced with the QSR. The QSR consists of the GMP regulations plus some new regulations that were added. The design control regulations were among those that were added and therefore are not part of GMP.

Having dispensed with this little history lesson, I think you will find your answer here:
CFR - Code of Federal Regulations Title 21
 

Ronen E

Problem Solver
Staff member
Super Moderator
#3
I work for a company that manufactures Class I weigh scales sold in the United States.
Several of the scales fall under product code INF (link)
The product is listed as GMP exempt, 510(k) Exempt.
The product may be battery powered or wall powered.
Where in the regulations does it state or imply that you would have to perform 60601 types of safety testing? (Is it solely based on the determination of risk and risk deemed acceptable by the company.... But it's design control exempt too... Right??)


Thanks for your time

Qu1nn
GMP is the old regulation that was replaced with the QSR. The QSR consists of the GMP regulations plus some new regulations that were added. The design control regulations were among those that were added and therefore are not part of GMP.

Having dispensed with this little history lesson, I think you will find your answer here:
CFR - Code of Federal Regulations Title 21
Interesting. I don't really get to deal with those "GMP exempt" devices (typically very low risk devices), but I always interpreted that exemption as saying "exempt from part 820 altogether". Since design controls are part of part 820 (820.30), I thought that the issue of design control applicability would be N/A for a "GMP exempt" code.

regardless of part 820, a requirement for electrical safety testing can come from subchapter J (parts 1000-1050) or from the NTRL (OSHA) scheme.
 
#4
I have the same view as Ronan, however i would like more clarification on this as It is a bit confusing. 21cfr 820, design controls section, says that class 1 devices are exempt from design controls and list the ones who are not exempt. But then the classification regulations of specific devices (other than the ones listed) reference the device is not GMP exempt. 21cfr 820 include the old Gmp and design controls and both together are the current GMP. This is my view, but is anyone here to confirm that GMP include design controls? GMP exempt means that is exempt of design controls as well? So why the regulations list only some devices, unless GMP and design control are not the same which i think they are. Thanks in advance
 
#5
is anyone here to confirm that GMP include design controls? GMP exempt means that is exempt of design controls as well? So why the regulations list only some devices, unless GMP and design control are not the same which i think they are. Thanks in advance
:soap:
Just to clarify, "GMP" and "design controls" are both concepts, without tangible reality, and people are free to decide for themselves what those concepts mean to them. However, they exist in reality only when they are defined, as in a regulation or a standard, and applied per the definitions. It is possible for different regulations and standards to define these concepts differently. ISO 13485 is a quality management system standard that includes design controls, as well as a lot of what was in the old FDA GMP regulation. Some people may think ISO 13485 is GMP; others may not. I have no idea what ISO thinks; I only know that it didn't call it a good manufacturing practice standard.

To reiterate, there is no longer an FDA GMP regulation, only a quality system regulation that includes the regulations that were once the GMP regulation, plus additional regulations. Design control regulations are among those that were added to the old GMP regulation to create the QSR. Given this history, I personally do not think design controls are part of "GMP," if for no reason other than there is no longer a GMP regulation for them to be part of. Of course, it gets confusing because there are still product codes that are called "GMP exempt." I think it is also confusing to refer to the QSR as "GMP," because design and manufacturing are two very different activities.

I think the FDA's design control regulations should have stood on their own, rather than being combined with the GMP regulation to create a quality system regulation. Further, if these regulations are really supposed to include the design of both product and process, those two should have been the subject of separate regulations as well. I don't know if it was done this way to confuse things, or whether those who created the QSR were confused. I know I am far from the only person who thinks CDRH itself has never really understood design control, and that it has failed to fully implement the design control regulations.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#6
if these regulations are really supposed to include the design of both product and process, those two should have been the subject of separate regulations as well.
I don't think that process design is actually "covered" anywhere. Some aspects are scattered, or worse - just implied, in various sections of part 820 (e.g. process validation), including design controls (820.30), and I feel it's not the result of a very conscious intention to address this topic in completeness.
I don't know if it was done this way to confuse things, or whether those who created the QSR were confused.
IMO the latter. Mind you, it's been many years since this structure was introduced, and in the meantime a lot of lessons have been learned both by the FDA and industry, and some insights and attitudes that were maybe missing back then have gelled.
Either way, to me FDA's announcement that it intends to bless ISO 13485 as a method to satisfy the QSR requirements is a sort of admission that the QSR is becoming outdated and that ISO's way "is better" or "has prevailed". ISO 13485 covers the modern-day offspring of the historical GMP concept, design controls, and some other things which are neither.
 
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#7
I don't think that process design is actually "covered" anywhere.
I only recently heard someone express the notion that the design control regulations apply to the design of manufacturing processes in addition to the design of the device to be manufactured. I had never heard anyone claim this before, and I remain skeptical. In any case, I have heard many people in the industry complain for years that insufficient consideration is given to the manufacturing process compared to the attention given to the design of the device, so I think addressing this subject separately and specifically would be a good thing.

Hanlon would agree with you. :D

FDA's announcement that it intends to bless ISO 13485 as a method to satisfy the QSR requirements.
Ummm....what announcement?
 

Ronen E

Problem Solver
Staff member
Super Moderator
#8
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#9
Indirectly, they do. You can't properly design a serially-manufactureable device without addressing its manufacturing process to a good extent.
And I think it would be of great benefit to everyone involved if this were addressed directly.

I'm familiar with those slides. Do you happen to know when and where they were presented? Just if you know off the top of your head...I tracked this down once and can do so again, if I really want to know.

An intention to "modernize and harmonize" FDA's regulation of medical device quality system was originally posted to the Unified Agenda in the Fall of 2018. The Unified Agenda is the agenda of the current Administration. Originally a Proposed Rule was to be released in April 2019, perhaps coincidentally the month that Gottlieb left the post of FDA Commissioner, or perhaps not. Then it was kicked forward to September 2019. Now it's been pushed to April 2020. It was not included in the Regulatory Plan for 2019, which identifies the different agencies' priorities and the most significant regulatory actions that they expects to take in the coming year.

As always, looking forward to see how it all plays out...
 
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Ronen E

Problem Solver
Staff member
Super Moderator
#10
Do you happen to know when and where they were presented?
No I don't.
When (or if) it will happen I do not know either. The point was that the FDA at one point "admitted" that ISO 13485 is at least as (or more) worthy as the QSR in its current state, arrived at through decades of implementation and (supposed) fine-tuning.
 
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