FDA announced it is seeking comment on a proposed list of alternative/streamlined mechanisms for complying with the CGMP requirements for combination products, such as: ● testing and release for distribution ● stability testing ● special testing require- ments ● reserve samples ● design controls, and ● devices that are exempt from all or certain provisions of the device Quality Sys- tem Regulation. The comment period ends September 11, 2018. [See IPQ May 11, 2018 for more on combination product GMPs.]
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