Tom Cowan

Tom Cowan

Knobbe Martens

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FDA Exempts Numerous Medical Devices from 510(k) Premarket Notification Requirements

The United States Food and Drug Administration (FDA) issued a Notice on July 11, 2017, exempting 1,003 Class II medical devices from premarket notification requirements under Section 510(k). The Notice indicates that anyone...more

8/15/2017  /  21st Century Cures Act , 510(k) RTA , Code of Federal Regulations (CFR) , Food and Drug Administration (FDA) , Medical Devices , Premarket Approval Applications
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