FDA 510(k) Summary and FDA 510(k) Statement

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Al Rosen

Staff member
Super Moderator
#2
Questions:
How can we handle the following situations:

1) We want to use one device as our predicate device. But there is only statement in FDA premarket notification database. How can we get the more information lik summary? We should request this information to FDA or to the predicate submitter.

2) We want to use one device which is cleared in the past 2 years as our predicate device. But neither summary nor statement is available in the FDA's database. How can to get the summary or statement?

3) For the 510k application document to be submitted to FDA, do we need to add the predicate's 510k summary or statement into the application files?
You can use a service like this one, but it could take up to 3 years to get if they don't have it.
 

Michael Malis

Quite Involved in Discussions
#3
Questions:
How can we handle the following situations:

1) We want to use one device as our predicate device. But there is only statement in FDA premarket notification database. How can we get the more information lik summary? We should request this information to FDA or to the predicate submitter.

2) We want to use one device which is cleared in the past 2 years as our predicate device. But neither summary nor statement is available in the FDA's database. How can to get the summary or statement?

3) For the 510k application document to be submitted to FDA, do we need to add the predicate's 510k summary or statement into the application files?
1. Freedom of information act will take a long time (up to 3 years) and still will not provide what you need.

2. :confused: Clarify if this is the same device as 1?

3. You don't need a summary or a statement from predicate device to submit a 510(k). What you need are "the claims". This will allow you to prove the your device and claims are equal to other device(s) and claims.
 
Last edited by a moderator:

Michael Malis

Quite Involved in Discussions
#5
Let me clarify the point, maybe I am missing something:

Go to the FDA website - www.hhs.gov
1. At the bottom of the page on the R side you will see "510k clearances"
2. Click and you will get to the next page
3. Than click on "Devices cleared in 2008", for example
4. Than click on appropriate month botton - for example, October 2008
5. Than click for example, on the first 510(k) # available K082464
6. When click on the number - K082464, you will get to the Summary of this 510k with the "Indications for Use" information that you need for your submission...
 
M

MIREGMGR

#10
If they chose the statement option, there is no summary.

Most companies use the summary approach because it's less trouble for them.

I wouldn't expect to get much information in the statement. They're likely to consider everything that they can get away with, to be exempt as a trade secret.
 
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