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Registering a Class 1 Sterile Medical Device - Currently selling a Non-Sterile

nozzle

Starting to get Involved
#1
Hi all :bigwave:
Was wondering if anyone could give me some guidance?
My company currently sell a non-sterile device in the US and are now looking at selling a sterile version of the same device.
Having read through the FDA guidance am I correct in thinking that the sterile device will have the same product code as the non-sterile? I've read through 21 CFR part 868 and can't see any specific requirements for registering the sterile device.

The organisation we intend to use for the sterilization are registered with the FDA.

Thanks in advance :)
 
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yodon

Staff member
Super Moderator
#2
Not in my area of expertise but this doesn't sound right to me.

A sterile product is quite different from a non-sterile. Material properties can be affected by sterilization, packaging has to be different, and management (expiration / shelf life) has to be different. Doesn't sound to me like using the same product code would be the right approach. Hopefully someone with expertise in this area will weigh in.
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Hard to say anything meaningful without knowing what the device is, what regulation it comes under within part 868 (868.xxxx) and what 3-letter code your current device is classified to.
 

JeantheBigone

Quite Involved in Discussions
#4
I can't think of any Class I devices that are sold both sterile and non-sterile, so I also find it hard to say anything meaningful.

I did find a thread here on the Cove about whether sterilization automatically means that a 510(k) is required, and someone was kind enough to post an example where this is not the case, namely for sterile liquid bandages.

https://elsmar.com/Forums/showthread.php?t=39448

Without knowing more, all I can suggest is to read 21 CFR 868.9 carefully to see if it trips subpart (a).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=868.9
 

nozzle

Starting to get Involved
#5
Hard to say anything meaningful without knowing what the device is, what regulation it comes under within part 868 (868.xxxx) and what 3-letter code your current device is classified to.
Thanks for your reply.
The device is a rigid Laryngoscope, 868.5540. Product code is CCW.

I've searched the FDA database for product code CCW, and from what I can see Dynarex Corp have sterile and non-sterile versions of the same device as our company listed. I can't post the direct link as I don't have enough posts on here yet.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Thanks for your reply.
The device is a rigid Laryngoscope, 868.5540. Product code is CCW.

I've searched the FDA database for product code CCW, and from what I can see Dynarex Corp have sterile and non-sterile versions of the same device as our company listed. I can't post the direct link as I don't have enough posts on here yet.
In short, if there is a (sterile) commercially distributed device under the CCW code that has the same characteristics as your sterile device, you'd be exempt from submitting a 510(k) for that device.

For full details, refer to 21 CFR 868.9.
 

JeantheBigone

Quite Involved in Discussions
#7
I tend to be a bit more (ok WAY more) cautious when it comes to relying on what other manufacturers have listed. It could be that they are in violation of the regulations, and FDA just hasn't gotten around to enforcing anything yet.

I'm not saying they are in violation, just that it's a possibility.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
FDA just hasn't gotten around to enforcing anything yet.
FDA doesn't actively chase class I devices. They're always under-resourced so I doubt that that will change anytime soon.

The way I see it, legally it's not the OP's responsibility to verify the precedent's classification. The regulation only requires similar characteristics as a device commercially distributed in the same category.

I do agree, though, that it won't be bad to have a backup, ie more than one such device which is sterile.
 

rwend07

Involved In Discussions
#9
I tend to be a bit more (ok WAY more) cautious when it comes to relying on what other manufacturers have listed. It could be that they are in violation of the regulations, and FDA just hasn't gotten around to enforcing anything yet.

I'm not saying they are in violation, just that it's a possibility.
If you've got several "predicates" (ideally from larger companies) listed in that product code that are sold sterile you should be fine. Sterility doesn't determine classification in the FDA as it does in the EU and elsewhere.
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Sterility doesn't determine classification in the FDA as it does in the EU and elsewhere.
...with the exception that some ProCodes explicitly say that they cover only a sterile device or only a non-sterile one.

I agree that there's no "classification rule" for sterility in the US system.
 
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