US FDA Lists Hundreds Of Devices For 510(k) Exemption
A list of devices being considered for 510(k) exemption includes allergens used in immune system testing, drug tests for employers and denture supplies. The agency is collecting comments through May 15.
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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.