Congress Unveils MDUFA Reauthorization Package

Congress Friday unveiled its first draft of MDUFA user fee reauthorizations, with total dollar amounts in line with those previously negotiated by regulated industry. Read More

FDA Publishes List of Class I Devices Exempt From 510K Reporting

The FDA has exempted more than 70 class I devices from pre-market notification requirements—seven of which are subject to some limitations. Read More

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