We ran across an interview with Owen Faris in The Gray Sheet, acting clinical trials director for CDRH. The position was established to help implement the several CDRH strategic priorities in 2014-15 that were announced in February focusing on speeding up the IDE review process and encouraging more IDE trials in the U.S.
CDRH also recently released an internal standard operating procedure for the review of IDEs. The SOPs address the process for initiating clinical trial director review and collaboration to resolve issues with IDE applications that lead to multiple review cycles.
Here are some of the highlights of the interview with Owen Faris:
- Main Goals for the pre-market clinical trials program?
The primary goal is to focus on reducing the number of cycles and the over time needed to reach appropriate full approvals for IDEs. However, an overarching goal is to get clinical trials started more quickly because the sooner devices are studied in the U.S., the quicker they can be marketed to patients in the U.S.
- What are the steps you will take to complete the IDE-focused strategic priorities?
The first (and key) step is going to be the implementation of the publically available SOP that walks through the interaction I will have with review teams to provide additional oversight and to leverage broader perspective from other review divisions to make sure we are in the right place.
- What guidance documents are in the works for IDEs?
An IDE decisions guidance has been in draft form twice because things have changed due to changes in the law. The second comment period for the document closed in September ’13, and CDRH will be issued very soon.
There is another guidance that is actively being worked on that has not been released in draft; it will be guidance for IDE benefit-risk.
- How will the benefit-risk IDE draft guidance differ from the IDE guidance that is being finalized?
It will be more about the thinking that goes behind our decisions – how we think about the benefits and risks for patients involved in clinical studies, and how that can guide us in make the right decisions.
- What are your long-term goals for CDRH’s pre-market clinical trials program?
The ultimate goal is improving the speed with which we get safe and effective medical devices to the market so they’re available beyond the more limited confines of the clinical study.
Getting clinical studies approved faster while still providing the appropriate subject protections is a major step toward that goal, but we also want to be working with sponsors to ensure that data being collected is the right data to support future marketing applications.
What do you think of the new CDRH’s clinical trials program? Please share your thoughts
Photo Credit: Pete Reed