Marianne, I have also found the FDA Ombudsman's office to be very helpful. In my case a company that had filed a 510(k) Statement instead of a Summary ignored a request to provide a redacted 510(k), sent by registered mail. The Ombudsman's office responded quickly to an email, found out which FDA office could help me, and introduced me to their staff via email. We had the redacted 510(k) a few days later.
I would recommend contacting DICE first in any case, but the Ombudsman's Office is a good second step.
------------------------------
Ian Broome, M.S., RAC
Needham, MA
United States
***Any posts or activity shared on RAPS Forums are my own personal views; I do not speak on behalf of Boston Scientific Corporation (BSC).***
------------------------------
Original Message:
Sent: 19-Nov-2021 09:12
From: Kimberly Chan
Subject: CDRH Ombudsman
That's great to know, thank you! I have never interacted with that office before, but my dealings with all FDA staff have been excellent so far in my short career.
------------------------------
Kimberly Chan
Lansdale PA
United States
Original Message:
Sent: 18-Nov-2021 12:15
From: Marianne Jacklyn
Subject: CDRH Ombudsman
Hello Community,
I want to share my recent positive experience with the CDRH Ombudsman office. I reached out with a question about process and the best contact to approach for the answer, and ended up with excellent guidance and insights on how to proceed for the specific situation. I had previously only thought of this office as the place to go for complaints and disputes, but they are also available to answer questions and provide guidance, confidentially, to avoid complaint-worthy situations. I wouldn't recommend going there with every question, but for tricky situations this route is worth consideration.
https://www.fda.gov/about-fda/center-devices-and-radiological-health/cdrh-ombudsman
Has anyone else interacted with this office?
Marianne
------------------------------
Marianne Jacklyn
Principal Consultant
West Linn OR
United States
------------------------------