Dear Anonymous,
I would suggest you contact them directly by formal registered letter. Under the law, they have just 30 days to respond and provide it. This is much shorter than requesting.under FOI and costs nothing for copy costs.
Downsides:
1) they can still redact much information or refuse.
2) they can see who you are.
For point 1) you can complain to FDA if it appears to be too heavily redacted or refuse but whether that gets you anywhere is anyone's guess. Then go through FOI.
For point 2) you could have a friend, family, lawyer, or consultant request it and the company would not know who was involved. Here, you could just use someone not in your company's location so it wouldn't be obvious it was coming from you. When I worked for one company, we once had a request from a law firm located in the same very small town in which the competitor was located . It was obvious the law firm was asking on behalf of the competitor. So be creative if you want to hide your company's identity.
PM me if you want me to send you a template letter I created to request 510ks directly from the company that filed a 510k Statement. I can send that to your e-mail.
Remember that the competitor could have moved or the contact listed on the 510k Statement may not be there anymore. I usually address these letters to the application correspondent or the RA or QA Manager.
Good luck!
------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com------------------------------
Original Message:
Sent: 04-Oct-2019 11:58
From: Anonymous Member
Subject: 510k statement - file request
This message was posted by a user wishing to remain anonymous
Unfortunately I didn't get any answer on my questions above. I try again and include an additional item:
- Do you think it would be acceptable to do this request by email?
Thanks for any help you can provide.
Original Message:
Sent: 25-Sep-2019 12:07
From: Anonymous Member
Subject: 510k statement - file request
This message was posted by a user wishing to remain anonymous
Hi all,
I am trying to collect info on predicates for a 510(k) submission. I found out that one of our predicates has a 510k statement (instead of a summary) so I am planning to request data from them directly. I have few questions on the procedure:
- is there any guidance for submitting such a request (e.g., specific wording to use)?
- Am I required to share with the company our identity?
- What to do, if the company sends us back a fully redacted 510k with no content at all?
Thanks in advance for your help.