Pre-IDE: How Much is Enough?

Wednesday, May 30, 2012

When working with clients on pre-IDE documents we almost always get the question: How much information do we need to put in a pre-IDE? My response to this question is: We need to include the information that will allow FDA to answer the questions we ask. No more, no less. FDA gets has an awful lot of these documents to read and it's critical that we provide targeted information that will lead to an informative discussion for both the Sponsor and FDA.

I suggest starting the process of developing a pre-IDE document by writing down:

  1. The intended use of the product
  2. The specific questions we want FDA to address.

When working on the questions make sure they are questions that can realistically be addressed by FDA during a review and/or meeting. For an original pre-IDE some examples of questions FDA may be able to address are:

  • Does FDA have any questions or input on the proposed intended use statement?
  • Does FDA see any specific technological issues that should be taken into consideration (i.e., design of assay, availability of controls, etc)
  • Does FDA agree with the proposed classification of the device and with the predicate device listed?
  • Does FDA agree with the list of analytical studies proposed by the Sponsor?
  • Does FDA agree generally with the approach to clinical studies and/or method comparison studies?

If these are the types of questions that you're hoping to discuss with FDA than the information that would be included in order to FDA to address them would likely be:

  • Detalled device description (including software, hardware and reagents)
  • Proposed intended use statement
  • Proposed regulatory classification for the product / proposed predicates
  • Summary of analytical studies to be performed
  • Summary of clinical and/or method comparison studies to be performed

Keep in mind that FDA is not a consulting organization. They can comment on proposals brought to them by Sponsors. They do their best to help but aren't in the position of being able to brainstorm or suggest product changes or possible uses.

If the product you're working with involves a new marker or use of an existing marker for a new intended use, information around why the marker should be measured and reported will be very important to include. We suggest including this information in a summary format, not just putting papers in and expecting FDA to weed through it. It may also be useful for truly new products to bring in physicians or other specialists that can address use of the product in the clinic.

It's also important to understand what types of questions FDA can't answer. For example, some customers want FDA to address timeline issues much too soon and will want to ask a question along the lines of "How long will it take for me to have 510(k) clearance?" Since FDA is not in control of development or study timelines this just isn't a realistic question. The other sort of question I advise clients to stay away from are provocative questions that intended to put FDA in a defensive position: "I was able to put a CE mark on this product and begin selling within three months. Our customers seem happy. Why are you making the process for clearance so difficult?" It is unlikely this sort of question is going to set the stage for productive discussions.

The last piece of wisdom that I'll pass along is starting the pre-IDE process with FDA is starting a conversation. The first review or meeting will only be the beginning of the discussions on the path to FDA clearance or approval. There will be opportunities down the road to ask detailed questions and receive detailed input on study protocols as well as other issues as we have more data.


Tags: 510(k), FDA, PMA

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