When do you have to do Clinical Trials for 510(K) submisson?

shimonv

Trusted Information Resource
#1
Hi Everyone,
Can anyone point out some guidelines as to when bench and animal studies are no longer sufficient and human trail is required?

I haven't seen any official guidance document on this subject.

Specific to our case, we have a series of tests to perform and for one of them we don't have enough of clinical (human) data, but we have retrospective animal data that we can use. Obviously, we want to avoid going for IRBs or IDE study.


Many Many Thanks,
Shimon
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: When do you have to do clinical trails for 510(K) submisson?

Hi Everyone,
Can anyone point out some guidelines as to when bench and animal studies are no longer sufficient and human trail is required?

I haven't seen any official guidance document on this subject.

Specific to our case, we have a series of tests to perform and for one of them we don't have enough of clinical (human) data, but we have retrospective animal data that we can use. Obviously, we want to avoid going for IRBs or IDE study.


Many Many Thanks,
Shimon
Hi Shimon,

FDA will always consider alternatives to clinical studies when the proposed alternatives are supported by an adequate scientific rationale. Our recommendations for clinical testing typically depend on many factors including device type, intended use, design, safety profile, and clinical experience.
Source: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm084365.htm

If your device type has a specific 510(k) preparation guidance document, it may be more specific with regards to the above. Maybe if you mention the type here you will get more specific advice as well.

Good luck,
Ronen.
 

JeantheBigone

Quite Involved in Discussions
#3
Re: When do you have to do clinical trails for 510(K) submisson?

If there is no guidance document it's left to the discretion of the reviewers. When submitting a 510(k) it's always a matter of proving safety and efficacy. My saying is that the bruden of proof for safety is determined by the FDA, while the burden of proof for efficacy depends on your marketing department.

If the bench and animal testing are sufficient to convince the reviewer that the device does not present a risk, you may not need clinical data for your 510(k).

Efficacy is something else. If you want to claim that your device is x-times as effective as the competition or y-times better than doing nothing, you have to prove that to the FDA review committee. If you can prove it without clinical data then you probably won't need clinical data.

You can try calling and asking for someone on the review panel to get a feel for whether they will want clinical data or not. Chances are they won't give you a straight answer but at least you can get an idea.
 
A

ascherp

#4
One situation where you always have to submit clinical information will be if your indications for use are new, i.e. if you don't have a predicate for your indications for use. Probably also if you are using a split predicate (one for indications for use, a different one for device specifications and design).

It may not be necessary to do a clinical trial though. Many times retrospective clinical data (gained from use of the device in Europe, for instance) will be sufficient for a 510(k).
 

shimonv

Trusted Information Resource
#5
Thanks everyone!!
Now I understand better the risk and effort involved.
I recon we can submit a 510(K) with bench and animal data and prepare a a fallback (clinical) data. By the time the reviewer will get to our file we should be able to submit additional clinical information.

Shimon
 
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