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FDA initiative aims to cut time between product development and patient access
The FDA hopes to expedite the production process of medical devices and simplify trials.
The FDA is launching an initiative to facilitate the development and availability of medical devices in order to make the transition from product creation to patient access faster and smoother.
The Medical Device Innovation Initiative will promote early interaction between the FDA and industry to optimize review times and further innovation, the FDA announced in a reent news release. The Center for Devices and Radiological Health (CDRH) plans to expand current efforts to promote scientific innovation in product development, focus device research on cutting-edge science, update how it reviews innovative devices and simplify the approach to clinical trials. The initiative will build on the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
With the medical device industry growing quickly, the FDA hopes to work more closely with industry to achieve better health outcomes with minimally invasive procedures, shorter recovery times and expedited clinical trials, the FDA said.
“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, MD. “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.”
The FDA also announced plans to issue new guidelines for clinical trials in order to modernize the medical device development process. Under these guidelines the FDA recommends using Bayesian statistical methods for both the design and analysis of clinical trials. This method would give industry the option of using prior information about safety and effectiveness in a mathematically acceptable way to design more efficient clinical trials. Depending on the type of data available, the FDA believes this could lead to shorter, less expensive clinical trials.
At press time, there was no indication of when this initiative would take effect.