New FDA Guideline for Medical Devices
On May 22, FDA announced their new Medical Device Innovation Initiative, which includes a new guidance document. This guidance is aimed at developing shorter and less expensive clinical trials through the use of Bayesian statistics.
Read FDA's Press Release, the Guidance Document, and the description of the Medical Device Innovation Initiative. Go to http://www.gmptrainingsystems.com/asp/resources.asp Scroll down or click on Medical Devices to find these three important documents.
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