FDA 510(k)-Exempts 72 Devices, Mostly Diagnostics
The US agency has exempted 72 different class I device types from the 510(k) requirement, effective April 13, using a procedure laid out by the 21st Century Cures Act. A majority of the products are in vitro diagnostics and reagents, but there also devices such as patient beds, restraints and first-aid kits.
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5 Figures On 510(k) Exemptions: What's The Impact Of US FDA's Recent Actions?
The 21st Century Cures act requires FDA to identify devices to exempt from 510(k) review, a mandate the agency fulfilled earlier this year. But what will be the tangible impact of the hundreds of new device codes removed from 510(k) requirements? This graphical analysis, conducted in collaboration with regulatory intelligence specialist Graematter, shows the effect may not be as large as the top-line numbers suggest. But select specialties and companies may see a few meaningful burdens lifted.
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.
21st Century Cures Implementation: Device Provision Updates
Dozens of reforms impacting the medtech sector were signed into law Dec. 13, 2016, in the 21st Century Cures Act. Here's a breakdown of where things stand in the implementation of key provisions.