Common Questions for Working on FDA Responses

By Linda Chatwin

  • Published 20.09.16
Time To Read 1 minute

On April 14, 2016, UL’s Linda Chatwin, RAC, JD and MasterControl’s Walt Murray hosted a webinar “Workin’ an FDA Response. Now What?” During this live webinar, several questions were asked from the over 180 industry participants. We are pleased to share these questions and the presenter’s responses.

You can view the webinar recording online with registration at: Recorded Webinar: Workin’ the FDA Response! Now What?

1. We just got FDA clearance on our first product. When do we expect an inspection by FDA?
A: Depending on the risk of the product that you have cleared, it could be anytime within the next three months up to two years. FDA approaches inspections on a risk based rationale, with the goal of inspecting Class IIs every 2 years.

2. Interested in your thoughts on external communications. The coverage on Theranos recently has been so damaging to them.

A: If the question is whether a company should provide communications to respond to allegations which might lead FDA to investigate, that should be discussed with company counsel.

3. Why do we identify “root cause”?
A: If there is a problem with a product that can be corrected, you must locate the root cause of the problem to ensure that you are correcting it at the lowest level possible, so that another issue that was deeper down won’t surface after you think you have worked a corrective action. For instance, perhaps a product that is designed to give some biological reading malfunctions, and during the analysis of the product, the company discovers that a battery malfunctioned. So, the battery is replaced and it seems all is well – until it malfunctions again, and they find that there is actually an algorithm in the code which draws power down.

4. It is difficult to decide whether we do catch root cause.
A: That is true. And sometimes it takes more than one try. But the team working on root cause should explore all possible causes before settling on one.
There could be more than one.

5. The root cause may not be root cause.
A: If it is not the root cause, typically that means that either the issue is a one-time issue without a cause that can be located, or that the investigation has not gone deep enough.

Please complete the form to download the full Q&A which includes answers to 7 questions asked live during the webinar.