Word: pre-market
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...submitted a pre-market notification for theGraduated Electronic Decelerator in April 1991.Officials say they have continued to supply theFDA with information on the decelerator during thepast three years...
...pre-market notification allows medicalinvestigators to use a new device withoutsubmitting to the more intensive InvestigationalDevices Exemption process. In this way, devicesnot intended for sale quickly receive approval foruse under the pre-market approval category...
According to this recent letter, the FDA hasdetermined "it is in the best interest of thepublic health that [BRI's] studies be conducted inaccordance with the full requirements of theInvestigational Device Exemptions regulation," asopposed to less thorough pre-market approvalprocess...
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