Obtaining Documents from the FDA in Frame of FOIA

[temujin]

Hi,

If I make a request for a 510(k) to the FDA in frame of the FOIA (Freedom of Information Act), will the FDA notify the applicant of the 510(k) that I (or somebody) has been given (or tried to obtain) this information?

regards
t.

[chris1price]

Yes, the first time it is requested, FDA will send a copy of the 510(k) to the company, who is allowed to sanitize it, blanking out all commercially sensitive information. I believe they also say who is requesting it. In the past I've used consultants to give more anominity to the request.

Note, this process is also very slow and can take 6 months or more before you get the 510(k). If it has already been requested by someone else, it may be quicker.

Also try FOI Services (www.foiservices.com), they keep a good stock of 510(k)s.

[temujin]

Thanks,

I already contacted the FDA, that said the 510(k) is already purged, and that it will take about 3 weeks to get it.

Yes, the first time it is requested, FDA will send a copy of the 510(k) to the company, who is allowed to sanitize it, blanking out all commercially sensitive information. I believe they also say who is requesting it. In the past I've used consultants to give more anominity to the request.

Can it be that this is the process of "purging" a 510(K). I mean if it´s already purged, the company will not receive the 510(k) for blanking out info?

regards
t.

[chris1price]

If its already been purged, you are right, it does not need to go back to the company, and they are unlikely to find out its been requested or who by.

[jjrey85]

Temujin,
I am trying to obtain a certain 510(k) for a dental implant, and I have the K number, but can you tell me how to request it? I tried the FOI site Chris1Price posted and they don't have it. Is there an online form or a phone number I can call to request the document? Any info you can give me is greatly appreciated. Thanks!

[MIREGMGR]

See this FDA web page for a complete explanation of what medical device info is available, and the different ways to obtain it.

[jjrey85]

Perfect! Thanks so much for the help

[temujin]

Good Luck!!

I wrote to the FDA in December 2007 in order to get the 510(k) for a purged product.

I am still waiting.