510(k) and DeNovo on same medical device for different indications?

anadal91

Registered
Hello All,

Looking for help from anyone with experience on a device that has undergone both a 510(k), and DeNovo clearance for different indications for use.

My startup has developed a Class II endoscope based medical device platform for use by gynecologists. The platform allows for many indications for use; some which are well known and qualify for 510(k) with third party review, and other indications that are completely novel and would require a DeNovo. Our plan is to move immediately on a 510(k) for the known indications (will help us start generating revenue), but we will need to conduct a pivotal study under IDE for the novel indications.

Do we run any risk with FDA if we submit our 510(k) for the known use as we have discussions with FDA on a proposed study to prove the novel indication for use? I'm unsure if doing both will compromise our ability to get the 510(k) clearance.

Appreciate any help.
 
Last edited:

shimonv

Trusted Information Resource
Hi anadal91,
I cannot imagine any problems moving forward this way; these are two separated submissions.
You wrote that "The platform allows for many indications for use", so it should not come as a surprise to FDA. You might even want to do the Pre-IDE meeting before submitting the 510(k) as I am sure you will gain some valuable information and feedback from them.

Shimon
 

anadal91

Registered
Hi anadal91,
I cannot imagine any problems moving forward this way; these are two separated submissions.
You wrote that "The platform allows for many indications for use", so it should not come as a surprise to FDA. You might even want to do the Pre-IDE meeting before submitting the 510(k) as I am sure you will gain some valuable information and feedback from them.

Shimon

Thanks so much Shinonv for the feedback! Good idea on the pre-IDE
 

mihzago

Trusted Information Resource
I don't see why you would run into problems. In fact, submitting a 510(k) for a device with simpler functionality or more general intended use before submitting another, more complex one, may be helpful and is often a good regulatory strategy.

Is your study determined to be Significant Risk? If no, then you may not need an IDE, but you could still do a Q-sub if you want feedback. Be careful with Q-sub though, you may get more feedback than you wish for.
 

anadal91

Registered
I don't see why you would run into problems. In fact, submitting a 510(k) for a device with simpler functionality or more general intended use before submitting another, more complex one, may be helpful and is often a good regulatory strategy.

Is your study determined to be Significant Risk? If no, then you may not need an IDE, but you could still do a Q-sub if you want feedback. Be careful with Q-sub though, you may get more feedback than you wish for.

Thanks for the feedback @mihzago. While we haven't approached FDA yet, we have some preliminary indication (based on other products) that we'd fall into SR and would need an IDE.
 

Orca1

Involved In Discussions
Submitting a 510(k) for known indications while simultaneously discussing a proposed study for novel indications with the FDA should not compromise your ability to get the 510(k) clearance. The FDA has separate processes for 510(k) submissions and Investigational Device Exemptions (IDEs) for clinical investigations.

For the known indications, you can submit a 510(k) premarket notification, which is subject to FDA review and clearance (21 CFR 876.1500(b)(1), 21 CFR 884.1060(b), 21 CFR 884.1185(b)). If your device falls under the exemptions listed in 21 CFR 864.9, you must still submit a premarket notification if the device is intended for a different use or operates using a different fundamental scientific technology than a legally marketed device in that generic type.

For the novel indications, you will need to conduct a pivotal study under an IDE (21 CFR 812.28(a)(2)(i), 21 CFR 812.28(a)(2)(ii), 21 CFR 812.28(a)(2)(iii), 21 CFR 812.36(b)). The FDA will consider the data from the clinical investigation conducted outside the United States to support an IDE or a device marketing application or submission (21 CFR 812.28(a)(3)).

Also it is important to ensure that your clinical investigations follow good clinical practice regulations, as outlined in the FDA Recognized Consensus Standard - ISO 14155 Third edition 2020-07.
 
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