FDA's opinion about a certain technology

LievenDW

Involved In Discussions
#1
We are planning to develop a new medical device of which there is no predicate device available. It uses a technology of which we are not sure if the FDA will allow it to be used (I apologize for not giving any details but you will understand this is confidential).
If we would be 100% sure that FDA will reject a device with this technology, we would not invest the development cost. Are there ways to find out upfront what FDA's opinion would be about using the technology (without giving an opinion on the eventual product of course)?
 
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M

MIREGMGR

#4
Since you need a formal response to guide your investment approach, you need to prepare and file a 513(g) application.

While a 513(g) process isn't normally used to determine whether the FDA will allow a technology to be utilized in a medical device, that is a sufficiently reliable outcome of the FDA analysis process that this is the right path for you.

See http ://www .fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm127147.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Your application will need to make clear the exact nature of the technology in question, in as much detail as you can provide, along with a clear statement of your uncertainty as to the acceptability of that technology to the FDA and your desire to have the FDA's response include consideration of that question. It's reasonable for you to include your analysis of the patient health benefits of acceptance of the technology, but this should be accompanied by a discussion of the risks and other potential negative aspects as well.

Note that, in your possibly-no-predicate situation, a 513(g) also will clarify whether your device will be considered Class III (probably critical to know up front), or require a separate De Novo process, or can follow the 510(k) path in spite of apparently not having a predicate, or whatever other classification approach they might conclude is required.
 
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yodon

Staff member
Super Moderator
#5
Note that, in your possibly-no-predicate situation, a 513(g) also will clarify whether your device will be considered Class III (probably critical to know up front), or require a separate De Novo process, or can follow the 510(k) path in spite of apparently not having a predicate, or whatever other classification approach they might conclude is required.
I've never seen or heard of this situation (new technology), so I presume the 513(g) route is a reasonable and wise approach. Two things in the response, though, jumped out at me. Without intending to hijack the thread:

1) If you can show safety and efficiacy, does the technology really matter?

2) If you can't identify a predicate device, aren't you required to go the PMA route?
 
M

MIREGMGR

#6
1) If you can show safety and efficiacy, does the technology really matter?
That depends. To craft an absurd example, what if the new product is physically addictive or somehow otherwise runs counter to social norms or social policy, but cures the common cold in seven days instead of ten?

I'm guessing the OP does have a serious question about something that the FDA or Congress might not like, but that nonetheless can deliver a medical benefit.

2) If you can't identify a predicate device, aren't you required to go the PMA route?
My understanding is that there have been instances in the past where the FDA has determined via the 513(g) route that a device may be cleared by the presentation of 510(k)-equivalent descriptive data but without the comparative content, after the FDA has determined that while the device is not SE (Substantially Equivalent) to a specific legally marketed device, it is equivalent in a composite sense to different aspects of multiple existing legally marketed devices.

It's also possible for a 513(g) process to result in a determination that a device should go straight to a De Novo process (513[f][2], http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080195.htm), in which case the non-SE device might be FDA-determined to be legally marketable in Class II without a 510(k) even having been filed.
 
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