The U.S. FDA’s device center is taking steps to improve the predictability of IDE reviews with the establishment of a new director-level position to oversee the clinical trials in the Office of Device Evaluation, a center official says.
The change, part of a broader reorganization within ODE, will also establish new procedures for the director’s involvement in IDE decisions and a focus on exercising flexibility where appropriate, ODE Deputy Director Barbara Zimmerman told Medcon 2015 in Cincinnati, Ohio.
Staff involved in reviewing IDEs will report to the trials director once the reorganization is complete, Zimmerman said.
In addition, ODE is designating managers as feasibility study directors. Sponsors planning an early study should contact the office directly to find out who their director will be, she said.
By the end of June, the device center hopes to reduce by 50 percent the number of IDEs requiring more than two cycles to be approved and reduce the overall median time for approval to 30 days. Companies whose trial proposals are rejected would hear from the agency within 10 days.
The changes are intended to strengthen the center’s clinical trial program, improve efficiencies and predictability in the IDE process and increase the number of early feasibility/first-in-human IDE studies conducted in the U.S., Zimmerman said.
Quynh Hoang, a former FDA official and senior regulatory consultant at King & Spalding, said firms going through any form of presubmission process should willingly accept FDA advice.
Hoang also suggests devicemakers include page numbers for easy reference in the acceptance checklist as a way to help build a good impression. She also advises companies that get requests for information from trial results to specifically address the question, rather than pointing to where information might be found in appendixes to the original application.
— Elizabeth Orr