US FDA Exempts 200 Device Types From Premarket Notification
Executive Summary
The US FDA has finalized regulations exempting hundreds of class I and class II medical devices from premarket notification requirements.
You may also be interested in...
FDA Exempts More Devices From Premarket Notification
A 22 July final order from the US FDA says makers of specific products that fall under five distinct device types don’t have to submit premarket notifications to the agency anymore. The FDA's latest exemption list comes seven months after it exempted 200 product types from premarket notification requirements.
US FDA: 510(k)-Exempt Class II Devices Should Withdraw Applications
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.
Addition to Quest Alzheimer's Suite Looks For Biomarker P-Tau217
The test is being integrated into Quest’s AD-Detect portfolio for assessing the risk of Alzheimer’s. It is the third p-tau217 test to make news this month, after new breakthrough designations for Quanterix and Roche and Eli Lilly.