FDA's Regulation of Combination Products - The Road Ahead
Abstract:FDA applies different regulatory requirements on products depending on whether they are medical devices, drugs or biologics. FDA has instituted various agencies to govern, enforce and update these regulations. But FDA has found it challenging to regulate products which are a combination of the categories.Though FDA has done well in regulating such products, industry feels the need for improvement in this area. Compliance is the need of the hour, but being compliant requires investment of time, resources and budget.
This article discusses the current approach in regulating combination products, problems with the current approach and the new developments in this regard which will make regulating these products more transparent, consistent and appropriate.
