IOM tells FDA to develop new regulatory pathway for medical devices

Abstract

Under the current regulatory process for medical devices, smart infusion pumps appear on the U.S. market before FDA evaluates their safety. So do the automated compounders many pharmacies use to prepare parenteral nutrient solutions. Since 1976, section 510(k) of the Federal Food, Drug, and Cosmetic Act has allowed a person to market a medium-risk medical device so long as it is “as safe, as effective, and performs as well as or better than the legally marketed device” identified in the “premarket notification.” FDA, the law states, reviews the pre-market notification and then takes one of the following actions: declares the new device “to be substantially equivalent to a legally marketed predicate device,” declares the new device “not substantially equivalent,” requests more information, or says the notification was unnecessary. “The 510(k) clearance process,” according to a new report from the Institute of Medicine (IOM), “is not intended to evaluate the safety and effectiveness of medical devices with some exceptions.”