What’s in a complete 510k filing?
Reading FDA 510k summaries is a great way to get started with the FDA. But, if you want to get more details about exactly what type of testing was performed. You can even get. Professional FDA consultants probably have tons of these, though. If you’ve never read a full 510k filing, start by skimming through one (here’s one for a fingertip pulse oximeter)
A full 510k FDA submission includes juicy details like:
How the device should be used
Software design specifications
Test Results – bench testing, animal testing, human testing
Defense of choice of predicates
Fees paid, dates things were filed, user manual
How to request a 510k FDA filing
The FDA’s Freedom of Information Act (FOIA) request form is here:http://www.accessdata.fda.gov/sc...
It’s a simple 4 step form, you’ll provide:
- Who are you (consumer, scholar, entrepreneur, etc)
- Fee information max – FDA charges fees for searching and printing. My requests were $15 and $25. Basically put the maximum you are willing to pay for the report as a cap
- Name, address, boring stuff
- Request details: a sentence or 2. Include the K number of the device, a link to the summary. I included a sentence like “Whatever information needs to be redacted is fine, I’m specifically interested in the indications for use section.” This means they can redact as needed or perhaps send you an already-edited version of the file.
510k Request samplesMassimo Rainbow Radical Pulse Oximeter Full 510k
(PDF, 73 MB)Zephyr Bioharness Full 510k
(PDF, 248 MB)
A lot of the information can be blacked-out (redacted) if the FDA or the developer determine the info is confidential. Things like specific patient data for instance, get the nix. Editing a 510k can take a reviewer time, which may cost you $$ or take extra time for the 510k to arrive at your door (see below for timeline)
How long does it take?
I filed 2 FOIA requests for 510ks and both of them hit my doorstep in under 2 weeks. In both cases the FDA sent me a burned CD with a PDF of the full 510k. Some FDA consultants say scary things like “it can take years!”. Though I doubt that’s the norm, be patient.
If you need speed is to try a a company like FOI Services
, who sells government documentation including 510k submissions. The quote I got was $300 for 1 510k document. They don’t have everything, only 1 out of 6 510ks I asked about, but it’s worth a shot because you’ll get the PDF immediately. Email them: email@example.com
Comment with any questions!