CRO and Client Disagreement

Here's my further response to the question from the Device Changes webinar of 03/20:

Ques:    What is a CRO's responsibility in educating the sponsor in whether or not the product is a medical device or not? Often times sponsors argue that their product is a cosmetic when it is more like a medical device.

Ans:   As I mentioned, I'm not qualified to directly answer this question.  It goes to the heart of how you as a CRO determine what potential clients you will accept as a formal client, and your legal department's and corporate policies.  As mentioned, as a consultant, I lay out the terms under which I will take on a client, and one of those is clarity of the definition of the project and its scope.  That includes agreement on applicable FDA requirements and definitions.  If the definition is subject to disagreement, then clarify what the proposal will address.

If the definition of cosmetic or device is not clear then define in your agreement just what your services cover, and the approach required by the FDA based on the definition chosen, and that the results are dependent on the chosen definition as it lays out the approaches taken.  This obviously has to be run through your legal department (as mentioned, I am not a lawyer and do not give legal advice). 

You have the right (and responsibility) to turn down clients that will not work with you, and certainly those who will not abide by FDA requirements.

Ref:  https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf

Hope that helps.

jel@jelincoln.com