Regulatory News

FDA Identifies More Than 70 Class I Devices Now Exempt From 510(k) Requirements

As part of its implementation of the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Wednesday released a list of more than 70 Class I medical devices that are now exempt from premarket notification requirements.

“FDA’s action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation,” the agency said in a notice.

The list includes a range of devices, from enzyme controls to clinical tonometers to drug specific control materials.

In some cases, the exemption from premarket notification requirements is limited to specific devices within a listed device type. For example, FDA lists the “exemption of the ataxiagraph device as 510(k) exempt, but limits the exemption to such devices that do not provide an interpretation or a clinical implication of the measurement.”

In developing the list, FDA says it considered its experience in reviewing premarket notifications for these devices, focusing on the risk inherent with the device and the disease treated or diagnosed, as well as the histories of adverse event reports and product recalls.

Notice With List of Class I Devices