Rx REPORT

FDA Announces Exemptions from Premarket Notification for Class II Devices

On July 11, 2017, FDA announced a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations.  FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA’s final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.

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