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70+ CLASS I DEVICES NOW EXEMPT FROM 510(K) REQUIREMENTS

by Arazy Group | Apr 25, 2017
The US Food and Drug Administration (FDA) has identified a list of over 70 class I devices that are now exempt from premarket notification requirements.

According to a notice issued by the FDA, its action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation.

FDA evaluated all class I devices to determine which types should be exempt from premarket notification requirements, taking into consideration its experience in reviewing premarket notifications for these devices, with a focus on the risk inherent with the device and the disease being treated or diagnosed. Other factors taken into consideration were the history of adverse event reports under the medical device reporting program for these devices, as well as their history of product recalls.

Contact us today for more information and to discover how regulatory intelligence and registration management system LICENSALE.COM® assists MedTech firms in gaining access to 100+ markets faster and more cost-effectively than ever before.
 
 
 

 

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