IOM tells FDA to develop new regulatory pathway for medical devices

Thompson, Cheryl A.
September 2011
American Journal of Health-System Pharmacy;9/15/2011, Vol. 68 Issue 18, p1672
Academic Journal
The article discusses infusion pumps which have flooded the U.S. market before the Food and Drug Administration (FDA) approved its safety. According to the author the Federal Food, Drug, and Cosmetic Act allows marketing of a medium risk medical device only when it is safe, effective and performs as well or better than the legally marketed device. Also the FDA will draft a guidance document about total product life cycle of infusion pump.


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