510k for Exempt Class I Medical Device - Industry Advantage to having a 510k Approval

Q

Quality96 - 2011

#1
I recently started at a new company (headquartered in Germany) and dicovered that they submitted a 510k for a device that is 510k exempt. And now we are in the final phase of developement on a new 510k exempt device and top management is asking if we should do a 510k, stating that there may be some industry advantage to having a 510k approval letter from the FDA. I see no market advantage at all to having a 510k on an exempt device; am I wrong? :confused:
 
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bio_subbu

Super Moderator
#2
Re: 510k for Exempt Class I Device

I understand that you are in the final stage of developing new product which is exempt from 510(k) and trying to get 510(k) approval letter from FDA for marketing advantage. Please understand the section 510(k) of the act and the implementing regulations in 21 CFR part 807 require persons who intend to market a new device to submit a premarket notification report (510(k) containing information that allows FDA to determine whether the new device is substantially equivalent within the meaning of section 513(i) of the FDCA to a legally marketed device that does not require premarket approval. Though your class I (General control) product exempt from premarket notification requirements, you won’t market a new device under section 510(k) of the act, unless you receive a substantial equivalence order from FDA or an order reclassifying the device into class I or class II, under section 513(f) of the act.

Thanks and Regards
S. Subramaniam
 
M

MIREGMGR

#3
Re: 510k for Exempt Class I Device

I admit to no direct experience with this, but my understanding is that under current rules, the FDA would refuse to process a notification for a device that was classified such that it should not require notification.

Given how rigorous the 510(k) examining process has become lately, I would think that some sort of smoke-and-mirrors approach would be required to cause them not to notice such a classification inconsistency.

Even if one were able to get such an application into review, how would one select an applicable predicate device that was already 510(k)-notification-accepted, already legally marketed, and could be classified equally to the submitted device?

If this can be done, my thanks for the opportunity to learn something new. :)
 
Q

Quality96 - 2011

#4
Re: 510k for Exempt Class I Device

Thanks bio_subbu,

Yes, I understand your points here. I should clarify that the new device in question is substantially equivalent to another legally marketed device the company has which is an exempt device, which we have a 510k clearance letter stating that the device is 510k exempt. The company is an FDA registered establishment, so it's my understanding that the companies only obligation in reference to exempt devices is to list the devices at the time of “Registration of Device Establishment”. My question is “Should we file a 510k for the new device that is basically an new version (with a completely different model/name) of an existing device (marketed by my company) that the FDA has already reviewed and deemed 510k exempt?”

Regards,

Bill
 
M

MIREGMGR

#5
Re: 510k for Exempt Class I Device

(...) the new device in question is substantially equivalent to another legally marketed device the company has which is an exempt device, which we have a 510k clearance letter stating that the device is 510k exempt. (...) My question is “Should we file a 510k for the new device that is basically an new version (with a completely different model/name) of an existing device (marketed by my company) that the FDA has already reviewed and deemed 510k exempt?”
If you're comfortable that the new version is still properly FDA classified as Class I, the question then is whether you regard the value of a letter from the FDA stating that your device is a I, as greater than your filing fee plus the time and resources to prepare the notification.

Does the history of the earlier model's similar letter show that that model's sales were aided sufficiently by the letter's existence to justify its costs?
 
Q

Quality96 - 2011

#6
Re: 510k for Exempt Class I Medical Device

Yes, I am very sure that the new device is substantially equivalent and is also 510k exempt. As for whether or not having a 510k for the predicate device aided sales. I'm not sure there is any way of knowing that due to the fact that the 510k has never been part of any marketing or sales literature.
 
M

MIREGMGR

#7
Re: 510k for Exempt Class I Medical Device

Between the filing fee and the preparation resources, I'd think the 510(k) submission would cost you at least $3K, even if you're mostly copying the prior submission. That makes the FDA's response-letter a pretty expensive piece of paper if it generates no sales/marketing value and isn't needed from a regulatory perspective.

That'd be my analysis, anyway.
 

bio_subbu

Super Moderator
#8
Re: 510k for Exempt Class I Device

Thanks bio_subbu,

Yes, I understand your points here. I should clarify that the new device in question is substantially equivalent to another legally marketed device the company has which is an exempt device, which we have a 510k clearance letter stating that the device is 510k exempt. The company is an FDA registered establishment, so it's my understanding that the companies only obligation in reference to exempt devices is to list the devices at the time of “Registration of Device Establishment”. My question is “Should we file a 510k for the new device that is basically an new version (with a completely different model/name) of an existing device (marketed by my company) that the FDA has already reviewed and deemed 510k exempt?”

Regards,

Bill

Dear Bill

The exemption from 510(k) is only the devices fall under the regulation (21 CFR 862-892). Kindly verify your product whether categorized in said regulation or not. Certain Class I or Class II devices can be marketed for the first time without having to submit a 510(k). However, if the device exceeds the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9), then a 510(k) must be submitted to market the new device.

The exemption limitations include the following:

a) the device has a new intended use,
b) the device operates using a different fundamental scientific technology than a legally marketed device in that generic type of device, or
c) the device is a reprocessed single-use device,
d) or if an IVD, the device is for lay use.

If your new device is substantially equivalent to another device legally marketed device, you can use as a reference for the clearance.

Thanks and Regards
S. Subramaniam
 
Q

Quality96 - 2011

#9
Re: 510k for Exempt Class I Medical Device

Thanks S. Subramaniam,

This is very usefull information.

Bill :agree1:
 
G

gar4guv

#10
Re: 510k for Exempt Class I Device

Thanks bio_subbu,

Yes, I understand your points here. I should clarify that the new device in question is substantially equivalent to another legally marketed device the company has which is an exempt device, which we have a 510k clearance letter stating that the device is 510k exempt. The company is an FDA registered establishment, so it's my understanding that the companies only obligation in reference to exempt devices is to list the devices at the time of “Registration of Device Establishment”. My question is “Should we file a 510k for the new device that is basically an new version (with a completely different model/name) of an existing device (marketed by my company) that the FDA has already reviewed and deemed 510k exempt?”

Regards,

Bill
Hi Bill,

My take on this is that it would be a waste of time and money to submit a 510(k) application. If you are sure that the new model will fall under the same Classification Product Code, then the regulation number tied to that code will tell you that it's exempt.

If I remember correctly, years ago the FDA didn't charge for pre-market notifications. So submitting one just to get a letter confirming the classification cost nothing. I can see a company doing that just to get something in writing stating that their product was 510k exempt. No such luck anymore.
 
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