jueves, 13 de abril de 2017

CDRH Industry: Class I Device Types Exempt from Premarket Notification

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Today’s Federal Register announces a list of 71 class I device types that the FDA is exempting or partially exempting from the premarket notification [510(k)] requirements. The list of exempted device types is final upon publication. The FDA believes that the device types identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness. This action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with Federal regulation. 
The Agency periodically exempts from premarket notification review such medical device types when appropriate.  On March 14, 2017, the Agency posted a list of 1,003 class II device types that the FDA is proposing to exempt or partially exempt from the premarket notification [510(k)]. 
The FDA is publishing this notice in accordance with streamlined procedures established by the 21st Century Cures Act. Unlike the list of class II device types, the 21st Century Cures Act does not require the FDA to solicit feedback on the class I list.  However, interested persons can submit comments about this notice by contacting Bryce Bennett (Bryce.Bennett@fda.hhs.gov).
Medical device types that are exempt from 510(k) are not exempt from other regulatory controls. All medical devices must be manufactured under current good manufacturing practice requirements, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA.
Thank you,

Center for Devices and Radiological Health
Food and Drug Administration

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