The US FDA is launching the Medical Device Innovation Initiative to make new medical devices available more quickly for patients. This broad initiative will promote early interaction between the FDA and industry to optimize review times and foster innovation. As outlined in a report released by the Agency, the Centre for Devices and Radiological Health (CDRH) will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least burdensome approach to clinical trials. This initiative builds on CDRH's strong scientific foundation and additional resources for the device review program provided under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
With the convergence of many scientific and technology breakthroughs, the pace of medical invention is accelerating, inspiring hope for better health outcomes with less invasive procedures and shorter recovery times. "We must keep up with the rapid developments in science and technology to ensure that patients have access to the most advanced treatments available," said FDA acting commissioner Andrew C. von Eschenbach, "By working with industry early in the evaluation process, we hope to foster development and speed up the approval of safe and effective innovative devices," he added.
As part of this initiative, FDA also announced today a critical step forward in modernizing the medical device development process by issuing new guidelines to outline the use of adaptive clinical trial designs. The draft guidance titled, "Bayesian Statistics in Medical Device Clinical Trials", provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. "Although this guidance is not yet final, it is a very exciting move in the direction of expediting new technology to the public," said CDRH Director Daniel Schultz. The use of Bayesian statistics offers industry the option of using prior, legally available information about safety and/or effectiveness in a mathematically acceptable way to design more efficient clinical trials, while still maintaining scientific rigor. Depending on the type of data available, this may lead to shorter, less expensive clinical trials.
With the additional resources from MDUFMA, CDRH is expanding its use of outside experts through the Medical Device Fellowship Program (MDFP). This expertise will assure that the Centre remains current on the latest technological and clinical advances. Over the past two years, CDRH has hired experts in many critical areas, including Anaesthesiology, Brachytherapy, Cardiothoracic Surgery, Electrophysiology, Human Factors Engineering, Neurosurgery, Nephrology, Paediatric Cardiology, Pulmonology, Radiation Oncology and Software Engineering. These experts will help FDA expedite the availability of new, cutting edge technology.
These exciting on-going initiatives will build on the successes of MDUFMA and further modernize the medical device review process in order to ultimately improve patient health and safety.