There is an atmosphere of frustration with the recent request for feedback from FDA on it’s proposed updated guidance document Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. Draft Guidance for Industry and Food and Drug Administration Staff. If you read between the lines, it sounds like FDA is not happy with the quality or quantity of Q-Sub requests, nor the content of the meetings, coming from industry. On the other hand, industry wants to be able to communicate with FDA early and often, as has been requested so often from the Agency. Industry also wants the feedback they receive from FDA to be informative, thorough, and binding. This should be true of interactive communications and Q-sub feedback and meeting minutes. The two sides of this conversation appear to be talking past each other, which is not helpful for FDA, industry, or patients. 

So, what’s the problem? Despite the constant call for predictability and transparency, industry still struggles with receiving consistent, least burdensome feedback from FDA. Industry is told repeatedly that they should make use of the communication channels available to them - namely the Q-sub process - to engage with FDA early and often throughout the pre-submission process, even during the development phase of medical products. But in this recent draft guidance update, FDA clearly states that the “the number of Q-Subs and Q-Sub supplements submitted should be carefully considered to avoid confusion and unnecessary expenditure of both FDA and industry time and resources.” So, which is it? Does FDA want us to be in communication with them? Or did their request for ‘early and often’ backfire such that they are receiving too many requests? 

Now from FDA’s perspective, it may be that industry isn’t using the Q-sub program wisely. FDA has the right to be more prescriptive in their request for how to use the Q-sub program if they are seeing requests that are not appropriate or a good use of FDA or industry’s time. For example, the Q-sub program should not be used to repeatedly ask the same question hoping for a different answer. (I’ve seen this reviewing historical documents, and the FDA response was one of my favorite smack downs of all time). Nor should the Q-sub process be used to try and end-run documented expectations for your product. If there is guidance or a standard stating precisely how your product should be tested, clinically validated, or otherwise documented as safe and effective, don’t use the Q-sub process to double check if FDA really, really means it. They mean it. Trying to cut corners is a waste of everyone’s time and a risk to patients.

It should also be recognized that a 1-hour meeting needs to be focused narrowly on specific questions that can only be answered in a pre-submission setting. Based on the language of the draft guidance, FDA is frustrated with the volume of questions they are expected to answer in one meeting. However, the draft guidance tries to prescribe which type of questions can be asked at what time in the product development process. This could backfire for sponsors who really do need more guidance early on to ensure they follow an efficient regulatory pathway to submission.  

RAPS Regulatory Focus recently summarized AdvaMed’s comments on the draft guidance, which stated, “...It is unclear if the increasing submission volume represents an overuse of the program and an underuse of more efficient methods of obtaining feedback, such as interactive review or emails and phone calls when the file is on hold.”  Depending on the answer to AdvaMed’s comment, the solution could be very different. Further, an analysis by Hyman. Phelps, and McNamara found that where FDA attempted to clarify when the Q-sub process should be used, the language in the guidance makes it even less clear when use of the Q-sub process is actually appropriate. I think we can all agree that FDA has the right to set expectations for efficient and appropriate interaction with their review teams. However, as medical product development continues to become more complex, along with the regulatory pathways we use to get them to market, FDA needs to find a balance between setting boundaries and putting up barriers to communication.