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.

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.

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.

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.

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!

See this FDA web page (http://www.fda.gov/cdrh/foi/cdrhinfo.html) for a complete explanation of what medical device info is available, and the different ways to obtain it.

Perfect! Thanks so much for the help

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.

:confused:

My most recent FOIA request to FDA--for two of our own 510(k)s from our early days, 30+ years ago, that over time we had lost our original reference copies of--took about eight months. The only records FDA had were on microfilm in an archival warehouse somewhere in Maryland. It took a long time for them to accumulate enough work to be done in that warehouse to schedule a trip there.

I'm not sure what detail of information you are looking for from the 510k, but you can also go to the CDRH 510k database website (below) and view the summaries of all 510k's submitted to FDA.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

This is the link to all of the CDRH databases:
http://www.fda.gov/cdrh/databases.html

These have been most useful to me in the past.

Good luck!