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.
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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.
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.
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.