Can you submit a traditional application for a class I device?

shimonv

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Hi Fellows,
I recently came across a summary for a traditional type of application for class I device which, according to product code and regulation, is exempt from premarket notification procedures: 510(k) Premarket Notification
Can anyone make sense of it?

Thanks,
Shimon
 

chris1price

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I was going to suggest the device was originally Class 2, a 510(k) obtained, and at a later date, the group down-graded to class 1, however, based on the 2018 date, that isn't the case.

Maybe they had a consultant who wanted to charge for a 510(k)?
 

shimonv

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They worked with Hogan Lovells - a very big and expensive law firm.
I just can't believe they would do that and I didn't know that FDA would be willing to review a class I application.

Still puzzled about this.
 
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shimonv

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As I look at the intended use and what the regulation says, it seems that if you are not sure that your product is indeed class I you can make a 510(k) to confirm this. Odd.
 

mihzago

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Most exempted devices have limitations of device exemptions, so it's quite possible the company wanted to introduce a device with significant changes to the technology or indications.

Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
 

Watchcat

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Yes, I can make sense of it. I did a pretty deep dive into this question for a client last year. If you aren't in a rush, I will dig up the analysis I sent to the client and get back to you next week. Short answer, I don't think there is a solid answer. I think FDA can probably do this if it wants to (or is pressured to do it by those with clout) but doesn't have to.
 

Watchcat

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Here's what I told my client:

It is not clear whether FDA will accept a 510(k) that claims substantial equivalence to a 510(k)-exempt device. The guidance on its website for selection of a predicate would seem to indicate that it will:

“…any legally U.S. marketed device may be used as a predicate. This includes: a device that has been cleared through the 510(k) process; a device that was legally marketed prior to May 28, 1976 (preamendments device); a device that was originally on the U.S. market as a Class III device (Premarket Approval) and later downclassified to Class II or I; or a 510(k) exempt device.”

Find and Effectively Use Predicate Devices

This information is identified as current as of 2018. However, FDA's 2019 refuse to accept checklists for 510(k) submissions seem to identify 510(k)-exempt devices as inappropriate for 510(k) submissions:

"FDA staff should determine whether the 510(k) submission is for a device type for which 510(k) is known to be an inappropriate regulatory approach, such as when the device type is Class III type and a PMA is required, or the device type is Class I or II and 510(k)-exempt."

For Elsmar Cove, I will add:
Of course, the latter is "just a guidance," that contains "nonbinding recommendations," so I'm still inclined to think that FDA can if it wants to. I doubt it would want to most of the time, unless it saw it as minimal work for a filing fee. I think it is unlikely to think the work will be minimal unless the 510(k) were submitted by a firm that has established a good track record with FDA. Another kind of "clout."

My client had no track record with FDA, so I told them I thought it was highly unlikely, but that I'd be happy to ask. They decided not to.
 
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