Special Controls and Class II Medical Devices

MikeKilkelly

Starting to get Involved
#1
Hi All,

I'm hoping someone here can help me better understand the FDA regulations regarding Special Controls for Class II medical devices.

As I understand it Special Controls are required for Class II devices and include Performance Standards, Post-market Surveillance, Patient registries, Special Labelling requirements, etc

CDRH has developed special controls guidance documents that specify requirements for individual devices. These Guidance documents are not available, however, for all or even the majority of Class II devices.

(Note: Product I am working on is a Powered Muscle Stimulator (Sec. 890.5850) and whilst a draft Class II Special Control Guidance Document was drafted in April 5, 2010, it was withdrawn on 27th Apr 2015.



Question 1:

In the absence of a special controls guidance document, what documents the particular special control requirements for a device?

Question 2:

There is now a Medical Device exemption list for Class II devices. How does the FDA decide which devices are exempted? Is it possible to propose a device for exemption?

(Note: While 890.5820 devices are not on the exemption list some others that are very similar are on the list.).
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi Mike,
Product I am working on is a Powered Muscle Stimulator (Sec. 890.5850)
This is a good starting point but for definite answers you'd have to tell us the ProCode (3-letter code) - there may be several under each regulation number. The ProCode page is very specific about the Special Controls prescribed/available for the specific type of devices.
whilst a draft Class II Special Control Guidance Document was drafted in April 5, 2010, it was withdrawn on 27th Apr 2015.
It's usually not a bad idea to voluntarily follow such guidance document even if it was withdrawn. Also not a bad idea to research what were the reasons for the withdrawal.
In the absence of a special controls guidance document, what documents the particular special control requirements for a device?
All and any clues would be found on the ProCode page. Sometimes a class II device doesn't actually have much of any Special Controls defined, though...
How does the FDA decide which devices are exempted?
I can't say I know exactly / for sure, but generally I think it's based on long safe (i.e. uneventful) use histories of devices under those codes. I vaguely recollect that they discussed it to some extent in the last guidance document that announced the last exemptions batch (several months ago IIRC).
Is it possible to propose a device for exemption?
I guess so, though I wouldn't expect any results too quickly.
 
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monoj mon

Trusted Information Resource
#3
Hi All,

I'm hoping someone here can help me better understand the FDA regulations regarding Special Controls for Class II medical devices.

As I understand it Special Controls are required for Class II devices and include Performance Standards, Post-market Surveillance, Patient registries, Special Labelling requirements, etc

CDRH has developed special controls guidance documents that specify requirements for individual devices. These Guidance documents are not available, however, for all or even the majority of Class II devices.

(Note: Product I am working on is a Powered Muscle Stimulator (Sec. 890.5850) and whilst a draft Class II Special Control Guidance Document was drafted in April 5, 2010, it was withdrawn on 27th Apr 2015.



Question 1:

In the absence of a special controls guidance document, what documents the particular special control requirements for a device?

Question 2:

There is now a Medical Device exemption list for Class II devices. How does the FDA decide which devices are exempted? Is it possible to propose a device for exemption?

(Note: While 890.5820 devices are not on the exemption list some others that are very similar are on the list.).

May be I will first look for the 510(k) summaries of the predicate devices as well as similar reference devices. Also, based on the 21 CFR Sec. 89.5850, I have found one guidance document, https://www.fda.gov/media/71804/download . As Ronen has said, I would also suggest to use the Guidance document that have mentioned, for reference. If there is still doubt, FDA always welcomes a pre-sub meeting in order to express their current thinking on the device type that you are working on.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
If there is still doubt, FDA always welcomes a pre-sub meeting in order to express their current thinking on the device type that you are working on.
Seems a bit of an overkill to me. Pre-subs take a lot of time. I would start with an email / call to DICE.
 
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monoj mon

Trusted Information Resource
#5
Seems a bit of an overkill for me. Pre-subs take a lot of time. I would start with an email / call to DICE.
True that, it indeed takes time. From requesting a probable date from the very busy schedule of the responsible person from FDA to have the in person/telephonic conversation, may be a long way for this special case of Mike. Email or call to DICE shall serve the purpose, but if the answers are not that simple and straightforward, I think sometime they may ask for a formal request with all the necessary information about the device.
 

Watchcat

Trusted Information Resource
#6
Hmm. I see this rather differently, but most of the time I will end up in the same place as Ronen E and monoj.

Special controls are anything your risk analysis indicates you should do to reduce risk, that is above and beyond general controls, e.g., biocompatibility testing, If you provide a compelling justification for your controls, then CDRH will "decide" that you have to have the special controls you already have. Neat trick, huh?

(I don't think CDRH ever came up with a special control itself, doubtful it would know how. It's lack of understanding of risk is why it is having such a hard time with De novos.)

That said, if you are dealing with a well-established 510(k) device, then the special controls have probably been well established too, so the controls in the 510(k) summaries for predicate devices will usually cover them. If they are really well established, FDA may have even reached a confidence level to put them into a guidance. I would still look to my own risk analysis first and foremost, but that's me.
 
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monoj mon

Trusted Information Resource
#7
Hmm. I see this rather differently, but most of the time I will end up in the same place as Ronen E and monoj.

Special controls are anything your risk analyses indicates you should do to reduce risk, that is above and beyond general controls, e.g., biocompatibility testing, If you provide a compelling justification for your controls, then CDRH will "decide" that you have to have the special controls you already have. Neat trick, huh?

(I don't think CDRH ever came up with a special control itself, doubtful it would know how. It's lack of understanding of risk is why it is having such a hard time with De novos.)

That said, if you are dealing with a well-established 510(k) device, then the special controls have probably been well established too, so the controls in the 510(k) summaries for predicate devices will usually cover them. If they are really well established, FDA may have even reached a confidence level to put them into a guidance. I would still look to my own risk analysis first and foremost, but that's me.
That's very well-put @whatchcat, the risk analysis usually should provide the content for special controls. So, it's very important to look for predicates and reference devices and if there are any adverse events related to them, specifically related to the safety and effectiveness of the device. If there is any performance standard then follow it to the best extent, if not then look for relevant standards and justify why those are suitable for your device. Establish a thorough post-market surveillance procedure, do in-depth clinical evaluation to justify if there is no need of clinical investigation. Conduct a regulatory evaluation for the labeling by going through Labels, IFU and any other relevant document from your predicate and reference devices. And always evaluate whether or not these information are enough to provide evidence for the safety and effectiveness of your device.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
That's very well-put @whatchcat, the risk analysis usually should provide the content for special controls. So, it's very important to look for predicates and reference devices and if there are any adverse events related to them, specifically related to the safety and effectiveness of the device. If there is any performance standard then follow it to the best extent, if not then look for relevant standards and justify why those are suitable for your device. Establish a thorough post-market surveillance procedure, do in-depth clinical evaluation to justify if there is no need of clinical investigation. Conduct a regulatory evaluation for the labeling by going through Labels, IFU and any other relevant document from your predicate and reference devices. And always evaluate whether or not these information are enough to provide evidence for the safety and effectiveness of your device.
I'm not sure where all this is coming from...?
I see here a mixture of common sense, EU regulatory requirements/expectations, supposedly best practices and what not. But actually very little actual FDA requirements.
I'm not saying that acting this way doesn't make sense, I'm just saying this is not how official FDA clearance works.
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Hmm. I see this rather differently, but most of the time I will end up in the same place as Ronen E and monoj.
Common sense / being wise aside, Special Controls are not some abstract concept open to a lot of personal interpretation. You might argue that implementation over the years has been lacking on CDRH's part, but the concept and the means are well-defined and I don't think musing about it and putting one's own spin on it will promote a smooth clearance process.
Special controls are anything your risk analysis indicates you should do to reduce risk, that is above and beyond general controls
I wonder where this is coming from, in a 510(k) context. The entire 510(k) framework contains very little reliance on (or reference to) each submitter's risk analysis. This has been a big difference between the USA and EU premarket paradigms for many years (though it's starting to change).
CDRH will "decide" that you have to have the special controls you already have.
AFAIK CDRH doesn't assign Special Controls on a case by case basis, but on a ProCode basis. They are set upfront (when a class II classification is created), and though they may be updated from time to time for most submitters they are a given (or they don't exist, and are not deemed necessary).
I don't think CDRH ever came up with a special control itself
Then I wonder who came up with all the existing Special Controls guidance documents.
That said, if you are dealing with a well-established 510(k) device, then the special controls have probably been well established too, so the controls in the 510(k) summaries for predicate devices will usually cover them.
That is a strange statement. Where specific Special Controls are established, they are stated on the ProCode webpage and there's no need to look for them in 510(k) summaries. Stated Special Controls are mandatory, so any predicate under the same ProCode would have had to comply with them, regardless of whether they are mentioned in the 510(k) summary (and some summaries are so telegraphic that they're not). The exception is a Special Control that was introduced after the predicate has already been cleared.
If they are really well established, FDA may have even reached a confidence level to put them into a guidance.
If they're not established to a level of a published guidance document, a performance standard or the likes, they're not Special Controls, as these are always specific, written, standardised and mandatory.
 
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monoj mon

Trusted Information Resource
#10
I'm not sure where all this is coming from...?
I see here a mixture of common sense, EU regulatory requirements/expectations, supposedly best practices and what not. But actually very little actual FDA requirements.
I'm not saying that acting this way doesn't make sense, I'm just saying this is not how official FDA clearance works.
My explanation is based on this from FDA's website,

1583908947415.png
And also, the explanation I provided is based on my experience for the 510(k) submission(s) that I made; specially for the "Performance Testing - Clinical"; in my cases I always provided few pages summary for the "Performance Testing - Clinical" and of course it is totally different from the "Clinical Evaluation" structure from EU perspective. For the "Performance Testing - Bench" my risk analysis file plays a great role in identifying the testing that has to be conducted for the safety and effectiveness of the device, if we also consider the adverse events related to the predicate device. These, I am saying, in the event when I don't find a clear list of special controls for my device or the "Product Code".
 
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