FDA Overhauls Medical Device Review Process
The U.S. Food and Drug Administration (FDA) is launching the Medical Device Innovation Initiative to shorten time to market for new medical devices. The Center for Devices and Radiological Health (CDRH) will modernize the review of innovative devices and facilitate a least burdensome approach to clinical trials. In this draft guidance for industry and FDA staff, the Centers calls for the use of Bayesian statistical methods to reach decisions on devices through shorter trials with smaller sample sizes. The Bayesian approach to statistics uses a consistent, mathematically formal method called Bayes’ Theorem for combining prior information with current information on a quantity of interest. It is becoming more commonly used thanks to increasing computer processing power.
The CDRH has also implemented a new process for prioritization of guidance document development and it intends to release guidance documents for innovative products such as drug eluting stents, combination device/biologic products for cartilage repair, and genetic and pharmacogenomic tests; as well as an intercenter guidance document on innovative combination products. Work will also be done on the critical path with new tools such as the development of anatomically and physiologically-accurate adult and pediatric virtual circulatory systems to assess the safety and effectiveness of new stent designs.
This initiative complements the FDA’s announcement last January of improved post-market review processes.
May 23, 2006 Related topics: Legal & legislative, Medical Devices & Products