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510k Approval - Does the FDA look for Clinical Data

ISO 13485 - Medical

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#1
Can anybody help......

We have clinical data whihc was used for our CE marking of the product, would we be able to use this submitting our 510k for the product?

Do the FDA look for clinial data obtained in the US for all submissions?

Thanks in advance
 
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yodon

Staff member
Super Moderator
#2
The best answer to this may be to advise you to hire a regulatory consultant. On the surface, I would think that if you complied with all the requriements for conducting clinical trials, then I would expect that you would be able to use the data. There are too many factors involving clinical trials and data collection though, to say for sure given just the information in the post.

Here's a link to the FDA site with a series of links regarding clinical trials:

http://www.fda.gov/oashi/clinicaltrials/default.htm

Hope you find something useful there.
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#3
Yodon is giving good advice.

In general, FDA does not expect clinical data for a 510(k), however, the trend is that they are asking for it more. I saw a statistic from about a year ago where the percentage of submissions requiring clinical data was somewhere around 5% in the early 2000s. Presently, however, the percentage is over 10%. Lots to consider, as yodon points out, so a consultant is a good idea.

Good luck.

Kevin
 
S

sanjoh

#4
In my experience with devices, the FDA has focused on:

1) How different or unique is the device from the predicate. And how well has the submitter been able to convey the risks associated with those differences.

2) If an accepted performance standard is defined for the device, the clinical data request rate is reduced.

3) In cases where the product is different can cadaver or computer simulation data address the differences.

4) IDEs are not fun and cost big $..... to be avoided for 510(k) products!
 
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