Complaints from end users to medical device manufacturers are unfortunately a common occurrence. Medical device manufacturers are expected to handle these complaints efficiently and effectively by keeping the end user or patient’s safety in mind. However not a lot of people think about how the FDA has to handle complaints from medical device manufacturers.

I am talking about complaints from a medical device manufacturer to the FDA specifically during the regulatory submission process. This process involves presubmission meetings, the actual submission and review period as well as after when a decision has been made. Often times issues come up during this process. Some people who are new to the medical device industry might want to know how to get their questions/issues solved when dealing with the FDA.

The CDRH Ombudsman is a group within the CDRH that handles and investigates complaints to the FDA. It is important for medical device manufacturers to know that this complaint handling aid within the CDRH is available. The role the CDRH Ombudsman has it to primarily investigate complaints that occur. This link explains more about what the CDRH Ombudsman is and what services are provided.

Additionally the CDRH Ombudsman also provides an annual report summarizing the types of handlings they face.

But how would be people know about the Ombudsman? What are some resources they can use to get more information about the complaint process to the FDA as well as even the appeal process on a submission?

There is a guidance available to explain the appeals process to the FDA and in there they talk about the Ombudsman group.

Additionally there is a new draft guidance available that was recently published and is under review to provide clarity to certain decision points in the complaints process. Primarily defining what a "significant decision is".

Have people sought guidance and advice from the CDRH Ombudsman before for specific complaints? If so what was the process like?


--Jillian F. Walker

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